BD VACUTAINER® SERUM
Report
- Report Number
- 1024879-2025-02162
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Date of Event
- November 22, 2025
- Report Date
- January 16, 2026
- Manufacturer
- BECTON DICKINSON & CO (FRANKLIN LAKES)
- Product Code
- JKA
- UDI-DI
- 30382903678120
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: BD RECEIVED TWO PHOTOS FOR INVESTIGATION, WHICH SHOW A TUBE WITH ITS STOPPER STUCK INSIDE AND THE STOPPER SEPARATED FROM ITS SHIELD. 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: CLOSURE SEPARATION. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D4. MEDICAL DEVICE LOT#: 5042703. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4).
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D4. MEDICAL DEVICE LOT#: 5042705 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4).
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, CLOSURE SEPARATION BETWEEN THE CAP AND RUBBER STOPPER WAS SEEN WITH ONE TUBE WHILE ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, CLOSURE SEPARATION BETWEEN THE CAP AND RUBBER STOPPER WAS SEEN WITH ONE TUBE WHILE ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, CLOSURE SEPARATION BETWEEN THE CAP AND RUBBER STOPPER WAS SEEN WITH ONE TUBE WHILE ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, CLOSURE SEPARATION BETWEEN THE CAP AND RUBBER STOPPER WAS SEEN WITH ONE TUBE WHILE ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2041266 | BD VACUTAINER® SERUM | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON DICKINSON & CO (FRANKLIN LAKES) | 5042705 | 30382903678120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |