BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 1917413-2023-01081
- Event Type
- Malfunction
- Date Received
- October 26, 2023
- Date of Event
- October 11, 2023
- Report Date
- January 14, 2024
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903630801
- PMA / PMN Number
- K013971
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING SHELF PACK LABEL WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE MISSING SHELF PACK LABEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10
THE FOLLOWING FIELDS WERE UPDATED: D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 28-DEC-2023. H6. TYPE OF INVESTIGATION: ADDITIONAL CODE B01 - TESTING OF ACTUAL/SUSPECTED DEVICE H6. INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE SHELF PACK AND 2 PHOTOS IN SUPPORT OF THIS COMPLAINT. VISUAL EXAMINATION OF THE SHELF PACK AND PHOTOS WAS PERFORMED AND REVEALED A MISSING LABEL ON THE SIDE OF THE SHELF PACK. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE MISSING SHELF PACK LABEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT 1 BOX OF BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES WAS FOUND WITHOUT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DOING LABELLING, WE FOUND 1 BOX OF 363080 (LOT NO. 3222676 EXP. 29.02.2024) WITHOUT BD LABEL
IT WAS REPORTED THAT 1 BOX OF BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES WAS FOUND WITHOUT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DOING LABELLING, WE FOUND 1 BOX OF 363080 (LOT NO. 3222676 EXP. 29.02.2024) WITHOUT BD LABEL.
IT WAS REPORTED THAT 1 BOX OF BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES WAS FOUND WITHOUT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DOING LABELLING, WE FOUND 1 BOX OF 363080 (LOT NO. 3222676 EXP. 29.02.2024) WITHOUT BD LABEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1674308 | BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 3222676 | 50382903630801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |