BD VACUTAINER® URINE COLLECTION CUP
Received Feb 17, 2020 · Event occurred Jan 24, 2020
Report 9617032-2020-00130 · MDR key 9716728
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton, Dickinson And Company (bd)Catalog number
364941
Lot number
SEE H.10
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
"MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9148917. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2019-05-28. MEDICAL DEVICE LOT #: 9232652. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2019-08-20. " 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 THAT THE CUPS LOOK DIRTY AND CLOUDY WITH A BD VACUTAINER® URINE COLLECTION CUP. THIS OCCURRED ON 30 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUPS LOOK LIKE DIRTY AND CLOUDY.
Description of Event or Problem
IT WAS REPORTED THAT THE CUPS LOOK DIRTY AND CLOUDY WITH A BD VACUTAINER® URINE COLLECTION CUP. THIS OCCURRED ON 30 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUPS LOOK LIKE DIRTY AND CLOUDY.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOUDINESS WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.