AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT
Received Jan 30, 2014 · Event occurred Jan 6, 2014
Report 0001119779-2014-00007 · MDR key 3598848
Device
Generic name
Device, Specimen Collection
Manufacturer
Bd Infusion Therapy Systems Inc. S.a. De C.v.Catalog number
446255
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Injury
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 (15-30ºC) OR (2-8ºC) FOR UP TO 72H. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. NO RETURNS WERE AVAILABLE AND NO BATCH NUMBER WAS PROVIDED FOR INVESTIGATION. AN INSPECTION OF THE USE OF THE PRODUCT, AS DIRECTED BY THE INSERT, IT APPEARS AS THOUGH THE COLLECTION SITE TOOK THE DROPPER TIP OFF WHEN DISPENSING THE ATTS SOLUTION INTO THE SAMPLE TUBE. THIS IS AGAINST THE PROCEDURE AND IS NOT TO BE DONE. BD RECOMMENDS THAT THE COLLECTION SITE FOLLOW THE PROCEDURE AS DIRECTED IN THE PRODUCT INSERT IN ORDER TO AVOID FUTURE INJURY. BD QA WILL CONTINUE TO MONITOR. A REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT DOES NOT INDICATE A CONFIRMED TREND FOR THIS ISSUE. DEVICE WAS NOT RETURNED TO MANUFACTURER FOR INVESTIGATION, SEE MANUFACTURER NARRATIVE BELOW.
Description of Event or Problem
CUSTOMER REPORTED THAT A TECH WAS INJURED WHILE RUNNING A PATIENT SAMPLE ON THE AFFIRM ASSAY. THE TECH CUT HER FINGER ON A GLASS SHARD INSIDE THE SPECIMEN TUBE. THE WOUND REQUIRED BASIC FIRST AID AND THE TECH WILL RECEIVE FOLLOW-UP TESTING FOR (B)(6).