BD VACUTAINER® URINE COLLECTION CUP
Received Sep 9, 2024 · Event occurred Aug 1, 2024
Report 9617032-2024-01436 · MDR key 20176370
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton, Dickinson And Company (bd)Catalog number
364941
Lot number
3129918
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BEFORE USING AN UNSPECIFIED NUMBER OF BD VACUTAINER® URINE COLLECTION CUPS, THE DEVICE LABELS WERE LIFTED OFF THE CUPS, STUCK TO OTHER CUPS. OR STUCK TO THE BAG IN WHICH THEY WERE STORED. THERE WERE NO HEALTH IMPACTS OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR LABEL LIFT WAS OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF LABEL LIFT. 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.