BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2024-00097
- Event Type
- Malfunction
- Date Received
- February 6, 2024
- Date of Event
- January 1, 2024
- Report Date
- February 9, 2024
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903686532
- PMA / PMN Number
- K980414
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D4. MEDICAL DEVICE LOT#: UNKNOWN D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K991088 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1024879-2024-00097 WAS SENT IN ERROR. THIS COMPLAINT IS A DUPLICATE AND HAS ALREADY BEEN REPORTED ON MFR REPORT # 1024879-2024-00067.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WAS INSUFFICIENT BLOOD FLOW SEEN IN 5 DEVICES. NO PATIENT IMPACT REPORTED.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WAS INSUFFICIENT BLOOD FLOW SEEN IN 5 DEVICES. NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504688 | BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | UNKNOWN | 50382903686532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |