KIT AFFIRM ATT SYSTEM 100 EA

Additional Manufacturer Narrative

IT WAS DETERMINED IN REVIEW OF THIS RECORD THAT THE INCORRECT GUIDELINE WAS USED TO COMPLETE THE DECISION TREE FOR THIS PRODUCT. A NEW NOT REPORTABLE DECISION TREE HAS BEEN COMPLETED USING THE MINOR FIRST AID GUIDELINES INSTEAD. AFTER REVIEW IT WAS DETERMINED THAT THE SAMPLE WAS NOT A PATIENT SAMPLE. THIS MDR SHOULD BE CONSIDERED CANCELLED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THE LABORATORY PERSONNEL HAD THEIR SKIN PUNCTURED WHILE BREAKING AN AMPULE WITH NO PATIENT SAMPLE. FIRST AID WAS APPLIED AND THERE WAS NO OTHER IMPACT REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING GLASS USER INJURY WHILE USING THE AFFIRM ATTS. PREVIOUS INVESTIGATION DID NOT REVEAL ANY CHANGES TO MATERIALS THAT COULD DIRECTLY CAUSE THIS INJURY. A REVIEW OF PAST COMPLAINTS DOES NOT INDICATE TREND BY ATTS BATCH. BD HAS IMPLEMENTED THE ATTS AMPULE CRUSHING TOOL IN ORDER TO PREVENT FUTURE OCCURRENCE OF THIS ISSUE. ALL CURRENT ATTS KITS CONTAIN 1 TOOL WHICH WILL BE PROVIDED IN EACH KIT INDEFINITELY. PER PACKAGE INSERT INSTRUCTIONS, BD STRONGLY RECOMMENDS USE OF THIS TOOL TO ELIMINATE CHANCE OF FUTURE INJURY. BD DEEPLY APOLOGIZES FOR ANY ISSUES THIS INCIDENT HAS CAUSED. WE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH ATTS GLASS INJURY. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THE LABORATORY PERSONNEL HAD THEIR SKIN PUNCTURED WHILE BREAKING AN AMPULE WITH PATIENT SAMPLE. FIRST AID WAS APPLIED AND THERE WAS NO OTHER IMPACT REPORTED.