BD VACUTAINER® URINE COLLECTION CUPS
Received May 12, 2026 · Event occurred Apr 14, 2026
Report 1917413-2026-00419 · MDR key 25155654
Device
Generic name
System, Transport, Aerobic
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
NS364975
Lot number
4213732
Product problems
- Blocked Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED ONE TIME WHILE USING BD VACUTAINER® URINE COLLECTION CUPS, A 3RD TUBE WAS UNABLE TO COLLECTED VIA THE CANNULA AND HAD TO MANUALLY ASPIRATE SPECIMEN INTO THE TUBE. THERE WAS 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
INVESTIGATION SUMMARY: BD RECEIVED TWO PHOTOS FOR INVESTIGATION, AND UPON EVALUATION OF THE TWO PHOTOS PROVIDED, NO ISSUES WERE IDENTIFIED. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: CLOG. 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 ONE TIME WHILE USING BD VACUTAINER® URINE COLLECTION CUPS, A 3RD TUBE WAS UNABLE TO COLLECTED VIA THE CANNULA AND HAD TO MANUALLY ASPIRATE SPECIMEN INTO THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.