FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® SST¿
MDR report key: 23512018
·
Received November 10, 2025
Report
- Report Number
- 1024879-2025-01753
- Event Type
- Malfunction
- Date Received
- November 10, 2025
- Date of Event
- October 14, 2025
- Report Date
- October 16, 2025
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 30382903679837
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
E1. INITIAL REPORTER PHONE #: (B)(6). E1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230855. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 1 TUBE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2582307 | BD VACUTAINER® SST¿ | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON, DICKINSON & CO., (BD) | 5101446 | 30382903679837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |