BD VACUTAINER® URINE COLLECTION CUP
Received Feb 29, 2024 · Event occurred Feb 7, 2024
Report 9617032-2024-00265 · MDR key 18813171
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton, Dickinson And Company (bd)Catalog number
364941
Lot number
3311209
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. RETAIN SAMPLE EVALUATION IS NOT AVAILABLE FOR THIS PRODUCT. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR LEAKAGE, BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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. H3 OTHER TEXT : SEE H10.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COLLECTION CUPS THAT SAMPLES WERE LEAKING. THIS OCCURRED TWENTY-FIVE (25) TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.