QUALICHECK, LEVEL 1
Received Apr 5, 2013 · Event occurred Mar 1, 2013
Report 3002807968-2013-00007 · MDR key 3050263
Device
Product problems
- Break
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
NO INVESTIGATION OF THE DEVICE IN QUESTION WAS PERFORMED.
Description of Event or Problem
NO PATIENT WAS INVOLVED IN THIS EVENT. THIS EVENT CONCERNS A USER ERROR WHERE A NURSE HURT HERSELF WHEN OPENING A GLASS AMPOULE. THE NURSE DID NOT USE THE RECOMMENDED AMPOULE OPENER (920-712) WHEN SHE OPENED A QUALICHECK LEVEL 1 AMPOULE. THE BREAK WAS UNEVEN AND LEFT A SHARP POINT WHICH PUNCTURED HER GLOVE AND CUT HER LEFT THUMB. IT IS RECOMMENDED TO USE THE AMPOULE OPENER WHEN OPENING QUALICHECK AMPOULES. WHEN BREAKING GLASS AMPOULES WITH THE HANDS, THERE IS AN INCREASED RISK OF HAND INJURY. ACCORDING TO THE SAFETY DATA SHEET THE POTENTIAL HAZARDS OF THE PRODUCT ARE CONSIDERED TO BE LIMITED. THE PRODUCT DOES, HOWEVER, CONTAIN A SMALL QUANTITY OF AN ALLERGENIC ADDITIVE WHICH CAN, IN DISPOSED INDIVIDUALS, CAUSE AN ALLERGIC REACTION. THE NURSE HAS REPORTED THAT SHE HAS NOT EXPERIENCED ANY ILL EFFECTS FROM THE INCIDENT. SHE HAS ALSO NOW BEEN PROVIDED WITH AN AMPOULE OPENER FOR FUTURE USE.