Table 1 Categories of use errors and close calls

Activation

a) failure to release the safety lock

(Phillips et al., 2011; Callis Duffin et al., 2016)

b) failure to push the button (at all, or with enough force)

(Fujioka et al., 2015; Callis Duffin et al., 2016; Robinson et al., 2014; Matfin et al., 2015; Demary et al., 2014; Salter et al., 2014; Brown et al., 2013)

c) failure to press the device against the injection site (at all, or with enough force)

(Sicherer et al., 2000; Salter et al., 2014; Brown et al., 2013; Guerlain et al., 2010a; Umasunthar et al., 2015; Bakirtas et al., 2011; Mehr et al., 2007; Arga et al., 2011; Topal et al., 2013; Edwards et al., 2013; Saleh-Langenberg et al., 2017; Hanna et al., 2016; Raffa et al., 2017)

d) duration of device-site contact too short

(Schmid et al., 2013)

e) unintentional activation

(Rohrer et al., 2013)

Compliance with procedures

a) attempt to disassemble device

(Guerlain et al., 2010a)

b) incorrect handling

(Salter et al., 2014; Hudry et al., 2017)

c) incorrect storage

(Sicherer et al., 2000; Schiff et al., 2016; Domańska et al., 2017)

d) failure to call the emergency medical services after the injection

(Brown et al., 2013; Saleh-Langenberg et al., 2017)

e) failure to massage the injection site after the injection

(Salter et al., 2014; Brown et al., 2013; Saleh-Langenberg et al., 2017)

f) failure to refer to the instructions for use (IFU)

(Jeannerot et al., 2016)

Disposal

a) incorrect device disposal

(Brown et al., 2013; Schiff et al., 2016)

b) incorrect needle disposal

(Lange et al., 2014; Schertz et al., 2011)

Dosage

a) incorrect dose setting

(Stauder et al., 2014; Fujioka et al., 2015; Rohrer et al., 2013; Jeannerot et al., 2016; Lange et al., 2014; Schertz et al., 2011; Pfützner et al., 2012; Mahony et al., 2015; Saunders et al., 2012)

b) dose misinterpretation/miscalculation

(Stauder et al., 2014; Fujioka et al., 2015; Jeannerot et al., 2016; Mahony et al., 2015)

c) failure to check the dose prior to injection

(Stauder et al., 2014; Schertz et al., 2011; Saunders et al., 2012)

d) failure to visually check the administered dose

(Phillips et al., 2011; Hudry et al., 2017; Schertz et al., 2011; Saunders et al., 2012)

Hygiene

a) failure to disinfect the injection site

(Schiff et al., 2016; Domańska et al., 2017; Jeannerot et al., 2016; Pfützner et al., 2012)

b) failure to wash hands

(Schiff et al., 2016)

c) touching the tip

(Salter et al., 2014; Guerlain et al., 2010a; Topal et al., 2013)

Injection

a) incorrect duration of injection

(Stauder et al., 2014; Lange et al., 2015; Sicherer et al., 2000; Phillips et al., 2011; Robinson et al., 2014; Matfin et al., 2015; Demary et al., 2014; Salter et al., 2014; Brown et al., 2013; Guerlain et al., 2010a; Umasunthar et al., 2015; Bakirtas et al., 2011; Mehr et al., 2007; Arga et al., 2011; Topal et al., 2013; Saleh-Langenberg et al., 2017; Raffa et al., 2017; Hudry et al., 2017; Schiff et al., 2016; Domańska et al., 2017; Lange et al., 2014; Schertz et al., 2011; Saunders et al., 2012; Pachon et al., 2014; Sheikh et al., 2016; Hanna et al., 2016; Guerlain et al., 2010b; Varunok et al., 2011)

b) incorrect pinching/folding of skin for injection

(Hudry et al., 2017; Schiff et al., 2016)

c) significant movement of the device during injection

(Guerlain et al., 2010a)

d) performance of several injections with same needle/device

(Guerlain et al., 2010a; Jeannerot et al., 2016)

e) incorrect injection site

(Stauder et al., 2014; Sicherer et al., 2000; Salter et al., 2014; Brown et al., 2013; Guerlain et al., 2010a; Bakirtas et al., 2011; Mehr et al., 2007; Arga et al., 2011; Topal et al., 2013; Saleh-Langenberg et al., 2017; Schmid et al., 2013; Schiff et al., 2016; Domańska et al., 2017)

Needle removal

a) incorrect removal from device

(Fujioka et al., 2015; Jeannerot et al., 2016; Schertz et al., 2011; Saunders et al., 2012)

b) incorrect removal from skin

(Schertz et al., 2011; Saunders et al., 2012)

Device orientation

a) device held upside-down

(Lange et al., 2015; Sicherer et al., 2000; Robinson et al., 2014; Matfin et al., 2015; Salter et al., 2014; Umasunthar et al., 2015; Bakirtas et al., 2011; Mehr et al., 2007; Arga et al., 2011; Topal et al., 2013; Schmid et al., 2013; Hudry et al., 2017; Domańska et al., 2017; Guerlain et al., 2010b; Saleh-Langenberg et al., 2017; Hanna et al., 2016; Andre et al., 2017)

b) device held at the wrong angle

(Phillips et al., 2011)

Preparation

a) incorrect needle attachment

(Stauder et al., 2014; Fujioka et al., 2015; Phillips et al., 2011; Lange et al., 2014; Schertz et al., 2011; Pfützner et al., 2012; Pfützner et al., 2010)

b) incorrect priming (flow and air bubble checking/removal)

(Stauder et al., 2014; Fujioka et al., 2015; Jeannerot et al., 2016; Lange et al., 2014; Schertz et al., 2011)

c) incorrect device selection

(Fujioka et al., 2015; Raffa et al., 2017)

d) failure to check device integrity

(Hudry et al., 2017; Schiff et al., 2016; Schertz et al., 2011; Saunders et al., 2012)

e) failure to check product validity

(Sicherer et al., 2000; Schmid et al., 2013; Hudry et al., 2017; Schiff et al., 2016)

f) tampering with the device

(Andre et al., 2017)

Protective/safety cap

a) incorrect cap removal

(Phillips et al., 2011; Brown et al., 2013; Saleh-Langenberg et al., 2017)

b) incorrect needle capping after the injection

(Phillips et al., 2011; Hudry et al., 2017; Jeannerot et al., 2016; Schertz et al., 2011; Mahony et al., 2015; Saunders et al., 2012)

c) cap not removed

(Fujioka et al., 2015; Sicherer et al., 2000; Robinson et al., 2014; Matfin et al., 2015; Salter et al., 2014; Guerlain et al., 2010a; Umasunthar et al., 2015; Bakirtas et al., 2011; Mehr et al., 2007; Arga et al., 2011; Schmid et al., 2013; Rohrer et al., 2013; Hudry et al., 2017; Lange et al., 2014; Schertz et al., 2011; Guerlain et al., 2010b; Brown et al., 2013; Topal et al., 2013; Hanna et al., 2016; Andre et al., 2017)

d) cap removed in the wrong order

(Salter et al., 2014; Guerlain et al., 2010a)