KIT AFFIRM ATT SYSTEM 100 EA

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING AN INCIDENT WHERE DURING PATIENT SPECIMEN COLLECTION AN AFFIRM SWAB HEAD DETACHED. QUALITY INVESTIGATION REQUIRED VENDOR INVESTIGATION. OUR SWAB MANUFACTURER (VENDOR) REVIEWED THE BATCH HISTORY RECORDS FOR THE BATCH IN QUESTION AND NO DISCREPANCIES WERE NOTED. THE VENDOR PERFORMED INSPECTIONS AND TESTING OF RETENTION MATERIALS FROM THE REPORTED BATCH AND NO FAILURES WERE ENCOUNTERED. OUR VENDOR WAS UNABLE TO DUPLICATE/CONFIRM THE CUSTOMERS REPORT. THE VENDOR REVIEWED THE PAST YEAR OF COMPLAINTS AGAINST THIS SWAB PRODUCT AND THERE WAS ONE OTHER COMPLAINT RELATED TO SWAB HEAD DETACHMENT (WHICH WAS SUBMITTED FROM THE SAME END USER AS THIS COMPLAINT). SEVERAL INQUIRIES WERE MADE WITH THE END USER IN ATTEMPTS TO DETERMINE IF THE SAME DOCTOR OR CLINICIAN PERFORMED THE COLLECTION OF BOTH (THE TWO) REPORTED INCIDENTS, HOWEVER, NO RESPONSE WAS RECEIVED. SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THE TIP OF THE SWAB BROKE OFF INSIDE THE PATIENT. THIS COULD LEAD TO SERIOUS INJURY AND NECESSITATE MEDICAL INTERVENTION. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT AFFIRM ATT SYSTEM 100 EA THE TIP OF THE SWAB BROKE OFF INSIDE THE PATIENT. THIS COULD LEAD TO SERIOUS INJURY AND NECESSITATE MEDICAL INTERVENTION. THERE WAS NO REPORT OF PATIENT IMPACT.