MalfunctionLIO
BD VACUTAINER® URINE COLLECTION CUP
Received May 8, 2018 · Event occurred Feb 27, 2018
Report 9617032-2018-01242 · MDR key 7495973
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton, Dickinson And Company (bd)Catalog number
364941
Lot number
8010514
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(6). BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.
Description of Event or Problem
IT WAS REPORTED THAT THE BD VACUTAINER® URINE COLLECTION CUP DID NOT HAVE A NEEDLE AT THE CUP CLOSURE.