AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT
Received Apr 23, 2014 · Event occurred Apr 1, 2014
Report 1119779-2014-00010 · MDR key 3815481
Device
Product problems
- Component Missing
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE AFFIRM ATTS COLLECTION KIT IS USED TO STABILIZE THE NUCLEIC ACID OF CANDIDA SPECIES, GARDNERELLA VAGINALIS, AND TRICHOMONAS VAGINALIS DURING SPECIMEN TRANSPORT AT AMBIENT TEMPERATURE (15-30 C) OR (2-8 C) FOR UP TO 72H. BD QUALITY WAS UNABLE TO CONFIRM THIS COMPLAINT DUE TO THE UNKNOWN LOT AND NO RETURN MATERIALS FOR INVESTIGATION. A COMPLETED REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT AS WELL AS INTERNAL QUALITY NOTIFICATIONS FOUND NO TRENDS FOR THIS ISSUE. BD QUALITY WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS TYPE OF ISSUE.
Description of Event or Problem
CUSTOMER CALLED TO REPORT AN INCIDENT THAT OCCURRED WHILE COLLECTING A VAGINAL SAMPLE FROM A PATIENT USING THE AFFIRM ATTS SAMPLE COLLECTION KIT. AS THEY WERE REMOVING THE COLLECTION SWAB FROM THE PATIENT THEY NOTED THAT THE COTTON TIP AT THE END OF THE SWAB WAS MISSING. THEY WERE UNABLE TO LOCATE THE COTTON TIP AND PROVIDED THE PATIENT WITH ANTIBIOTICS AS A PRECAUTION.