BD VACUTAINER® SERUM
Report
- Report Number
- 1024879-2025-02059
- Event Type
- Malfunction
- Date Received
- December 10, 2025
- Date of Event
- November 14, 2025
- Report Date
- March 5, 2026
- Manufacturer
- BECTON DICKINSON & CO (FRANKLIN LAKES)
- Product Code
- JKA
- UDI-DI
- 30382903678205
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: G.4. PMA / 510(K)#: K960250. INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND UNDERFILL 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: UNDERFILL. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566824 | BD VACUTAINER® SERUM | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON DICKINSON & CO (FRANKLIN LAKES) | 4163271 | 30382903678205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |