BD VACUTAINER® URINE COLLECTION CUP
Report
- Report Number
- 9617032-2022-00133
- Event Type
- Malfunction
- Date Received
- February 24, 2022
- Date of Event
- February 16, 2022
- Report Date
- April 13, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- KDT
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1249257 MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2021-09-06. MEDICAL DEVICE LOT #: 1152713. MEDICAL DEVICE EXPIRATION DATE: 2023-05-23. DEVICE MANUFACTURE DATE: 2021-06-01. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 23-MAR-2022. H.6. INVESTIGATION: BD RECEIVED TWO (2) SAMPLES (1 FROM EACH LOT 1088376 AND LOT 2004312) AND ONE (1) PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED SHOWING (LOT 1249257; LOT 1152713; LOT 1292218) URINE CUPS AND THE INDICATED FAILURE MODE FOR LABEL LIFT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR LABEL LIFT WITH THE INCIDENT LOT WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF LABEL LIFT BASED ON THE RETURNED SAMPLES AND PHOTO. EVALUATION OF BOTH INDICATED THAT THE LABELS WERE MISPLACED AND SOME OF THE SAMPLES HAD NO LABELS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1249257. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2023. H.4. DEVICE MANUFACTURE DATE: 06-SEP-2021. D.4. MEDICAL DEVICE LOT #: 1152713. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2023. H.4. DEVICE MANUFACTURE DATE: 01-JUN-2021. D.4. MEDICAL DEVICE LOT #: 1088376. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2023. H.4. DEVICE MANUFACTURE DATE: 29-MAR-2021. D.4. MEDICAL DEVICE LOT #: 2004312. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2023. H.4. DEVICE MANUFACTURE DATE: 04-JAN-2022. D.4. MEDICAL DEVICE LOT #: 1292218. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2023. H.4. DEVICE MANUFACTURE DATE: 19-OCT-2021.
THE FOLLOWING FIELDS HAVE BEEN UPDATED VIA ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. D.4. MEDICAL DEVICE LOT #:SEE H.10. D.4. MEDICAL DEVICE LOT #: 1088376. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. H.4. DEVICE MANUFACTURE DATE: 2021-03-29. D.4. MEDICAL DEVICE LOT #: 2004312. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. H.4. DEVICE MANUFACTURE DATE: 2022-01-04.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP, THE DEVICE EXPERIENCED LABEL LIFT/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: - AS THE CONTAINER IS NOT PRESENTED IN A PROTECTED ATMOSPHERE PACKAGING, THE ONLY PROTECTION AVAILABLE TO THE CONTAINER AGAINST CONTAMINATION OF THE PROTECTED NEEDLE ON THE LID IS THE LABEL ON THE NEEDLE AREA OF THE LID. HOWEVER, AS CAN BE SEEN IN THE IMAGE, THESE LABELS, WHICH SERVE AS A SECURITY SEAL ON THE NEEDLES OF THE LID, ARE PEELING OFF."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP, THE DEVICE EXPERIENCED LABEL LIFT/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AS THE CONTAINER IS NOT PRESENTED IN A PROTECTED ATMOSPHERE PACKAGING, THE ONLY PROTECTION AVAILABLE TO THE CONTAINER AGAINST CONTAMINATION OF THE PROTECTED NEEDLE ON THE LID IS THE LABEL ON THE NEEDLE AREA OF THE LID. HOWEVER, AS CAN BE SEEN IN THE IMAGE, THESE LABELS, WHICH SERVE AS A SECURITY SEAL ON THE NEEDLES OF THE LID, ARE PEELING OFF.".
IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP, THE DEVICE EXPERIENCED LABEL LIFT/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AS THE CONTAINER IS NOT PRESENTED IN A PROTECTED ATMOSPHERE PACKAGING, THE ONLY PROTECTION AVAILABLE TO THE CONTAINER AGAINST CONTAMINATION OF THE PROTECTED NEEDLE ON THE LID IS THE LABEL ON THE NEEDLE AREA OF THE LID. HOWEVER, AS CAN BE SEEN IN THE IMAGE, THESE LABELS, WHICH SERVE AS A SECURITY SEAL ON THE NEEDLES OF THE LID, ARE PEELING OFF.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP, THE DEVICE EXPERIENCED LABEL LIFT/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AS THE CONTAINER IS NOT PRESENTED IN A PROTECTED ATMOSPHERE PACKAGING, THE ONLY PROTECTION AVAILABLE TO THE CONTAINER AGAINST CONTAMINATION OF THE PROTECTED NEEDLE ON THE LID IS THE LABEL ON THE NEEDLE AREA OF THE LID. HOWEVER, AS CAN BE SEEN IN THE IMAGE, THESE LABELS, WHICH SERVE AS A SECURITY SEAL ON THE NEEDLES OF THE LID, ARE PEELING OFF.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2358535 | BD VACUTAINER® URINE COLLECTION CUP | SPECIMEN TRANSPORT AND STORAGE CONTAINER | KDT | BECTON, DICKINSON AND COMPANY (BD) | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |