BD VACUTAINER® URINE TRANSFER STRAW
Received Jan 16, 2026 · Event occurred Dec 19, 2025
Report 1917413-2025-01771 · MDR key 24095307
Device
Generic name
System, Transport, Aerobic
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
364966
Lot number
5070151
Product problems
- Separation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® URINE TRANSFER STRAW, 2 DEVICES WERE FOUND TO HAVE SEPARATED WITH NEEDLE EXPOSED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES H.3 DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 30-JAN-2026 INVESTIGATION SUMMARY BD RECEIVED 928 SAMPLES FOR INVESTIGATION. THE SAMPLES INDICATE THAT THE COMPONENTS OF THE TRANSFER DEVICE HAVE BECOME SEPARATED. 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: SEPARATES. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® URINE TRANSFER STRAW, 2 DEVICES WERE FOUND TO HAVE SEPARATED WITH NEEDLE EXPOSED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.