BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE
Received Sep 30, 2024 · Event occurred Sep 4, 2024
Report 9617032-2024-01583 · MDR key 20335433
Device
Generic name
Container, Specimen Mailer And Storage, Sterile
Manufacturer
Becton, Dickinson And Company (bd)Catalog number
368500
Lot number
4129965
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR CORING WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF CORING WAS NOT 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 CORING. BD WAS NOT ABLE TO IDENTIFY AN EXACT 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE THAT FOUR (4) TUBES EXPERIENCED CORING OF THE STOPPER. PIECES OF RUBBER STOPPER FELL INSIDE THE TUBE DURING TRANSFER OF THE SAMPLE FROM THE COLLECTION CUP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.