BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
Report
- Report Number
- 2243072-2026-00254
- Event Type
- Malfunction
- Date Received
- April 3, 2026
- Date of Event
- February 24, 2026
- Report Date
- May 7, 2026
- Manufacturer
- BECTON DICKINSON & CO (FRANKLIN LAKES)
- Product Code
- JKA
- UDI-DI
- 30382903672975
- PMA / PMN Number
- K980414
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (NIPRO). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3: DEVICE EVAL BY MANUFACTURER? YES. D.9: RETURNED TO MANUFACTURER ON: 15-APR-2026. G.4. PMA / 510(K)#: K252506. INVESTIGATION SUMMARY: BD RECEIVED FIVE CUSTOMER SAMPLES AND TWO PHOTOS FOR EVALUATION. REVIEW OF THE PHOTOS DID NOT DISPLAY THE REPORTED FAILURE MODE OF INSUFFICIENT BLOOD FLOW FOR THE INCIDENT LOT. THE FIVE CUSTOMER SAMPLES, ALONG WITH 50 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED THROUGH VISUAL EXAMINATION, AND NO ISSUES RELATED TO INSUFFICIENT BLOOD FLOW WERE OBSERVED, ALL SAMPLES MET APPLICABLE SPECIFICATIONS. ALSO, THE FIVE CUSTOMER SAMPLES, TOGETHER WITH EIGHT RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING, AND NO ISSUES ASSOCIATED WITH INSUFFICIENT BLOOD FLOW WERE IDENTIFIED, ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE INCIDENT LOT CONFIRMED THAT ALL PRODUCT SPECIFICATIONS AND LOT RELEASE REQUIREMENTS WERE MET, WITH NO RELATED QUALITY ISSUES IDENTIFIED DURING MANUFACTURING. BASED ON THE AVAILABLE INFORMATION, THIS COMPLAINT COULD NOT BE CONFIRMED FOR THE REPORTED FAILURE MODE OF INSUFFICIENT BLOOD FLOW, AND NO ROOT CAUSE COULD BE IDENTIFIED. 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.
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, RESISTANCE IS SEEN DURING BLOOD DRAW USING AN UNSPECIFIED NUMBER OF DEVICES. WHEN THE NURSE ENGAGES THE YELLOW NEEDLE SHIELD, ANY BLOOD THAT IS IN THE TUBING SHOOTS OUT OF THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, RESISTANCE IS SEEN DURING BLOOD DRAW USING AN UNSPECIFIED NUMBER OF DEVICES. WHEN THE NURSE ENGAGES THE YELLOW NEEDLE SHIELD, ANY BLOOD THAT IS IN THE TUBING SHOOTS OUT OF THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270463 | BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON DICKINSON & CO (FRANKLIN LAKES) | 25J2581 | 30382903672975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |