BD VACUTAINER® URINE COLLECTION CUP
Received Jan 18, 2024 · Event occurred Dec 26, 2023
Report 9617032-2024-00041 · MDR key 18538036
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton, Dickinson And Company (bd)Catalog number
364941
Lot number
3284447
Product problems
- Component Missing
- Component Missing
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP CUSTOMER HAD RECEIVED 1000 CUPS WITHOUT A LID. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. RETAINED SAMPLES EVALUATION IS NOT AVAILABLE FOR THIS PRODUCT. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP CUSTOMER HAD RECEIVED 1000 CUPS WITHOUT A LID. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.