FEMALE ENDOCERVICAL SPECIMEN COLLECTION KIT FO

Description of Event or Problem

THE COLLECTION KIT WAS USED OFF LICENSE TO SWAB A MALE RECTUM FOR (B)(6) IN THE (B)(6) CLINIC. THIS TYPE OF SWAB IS USED ACROSS (B)(6) FOR THIS INDICATION. THE SWAB BROKE OFF HALF WAY ALONG ITS NATURAL FRACTURE POINT AND GOT LOST IN THE PT'S RECTUM. THE PT SPENT MOST OF THE DAY IN THE A&E UNDER THE SURGEON'S CARE TRYING TO RETRIEVE THE SWAB BY USING PROCTOSCOPY, RIGID SIGMOIDOSCOPY, MULTIPLE ENEMAS AND FLEXIBLE SIGMOIDOSCOPY. THE SWAB COULD NOT BE FOUND AND IT WAS ASSUMED IT CAME OUT IN THE STOOL AFTER THE ENEMAS. THE PT REMAINED CLINICALLY WELL THROUGHOUT AND WAS DISCHARGED HOME. THREE DAYS LATER, A FOLLOW UP CALL CONFIRMED THAT HE WAS STILL WELL. MINOR BLEEDING WAS EVIDENT IN THE RECTAL AREA.

Additional Manufacturer Narrative

THE SPECIMEN USAGE FOR THIS PRODUCT AS INDICATED IN THE PACKAGE INSERT IS "...USED TO COLLECT AND TRANSPORT PT ENDOCERVICAL SPECIMENS TO THE LABORATORY FOR TESTING...." IN THIS INSTANCE, THE PRODUCT WAS USED IN AN OFF CLAIMS MANNER AS ADMITTED BY THE CUSTOMER. NO TESTING OR VALIDATION HAS BEEN PERFORMED TO SUBSTANTIATE THE USER OF THE SWAB FOR COLLECTION OF PT RECTAL SPECIMENS. THERE HAVE BEEN NO OTHER COMPLAINTS ON THIS PRODUCT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. BD WILL CONTINUE TO MONITOR THIS PRODUCT.