BD MOLECULAR SWAB COLLECTION KIT

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INITIAL REPORTER E-MAIL:(B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING THE BD MOLECULAR SWAB COLLECTION KIT THAT THERE WAS A SWAB TIP OR SHAFT BREAK. MAX 443925 VAGINAL COLLECTION SWAB ISSUE.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR BROKEN SWAB WHEN USING THE BD MOLECULAR SWAB COLLECTION KIT 100EA (REF #443925) UNKNOWN LOT NUMBER WAS PERFORMED BY THE VERIFICATION OF COMPLAINTS HISTORY. CUSTOMER COMPLAINED ABOUT A SWAB FROM UNKNOWN LOT WHICH BROKE OFF DURING A VAGINAL SWAB SELF-COLLECTION, AT A COLLECTION SITE. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION FROM THE CUSTOMER, NO LOT INFORMATION WAS RECEIVED NOR ANY INDICATION ABOUT WHICH AREA OF THE SWAB BROKE OFF WERE NOT PROVIDED FOR INVESTIGATION. THERE IS NO INDICATION OF BROKEN SWAB ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED ON BD MOLECULAR SWAB COLLECTION KIT 100EA PRODUCTS. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING THE BD MOLECULAR SWAB COLLECTION KIT THAT THERE WAS A SWAB TIP OR SHAFT BREAK. MAX 443925 VAGINAL COLLECTION SWAB ISSUE