UROVAC¿ BLADDER EVACUATOR
Received Apr 25, 2018 · Event occurred Apr 9, 2018
Report 3005099803-2018-01284 · MDR key 7462373
Device
Generic name
Evacuator, Bladder, Manually Operated
Manufacturer
Boston Scientific - SpencerModel number
M0067301251Catalog number
730-125
Lot number
20872043
Product problems
- Device Packaging Compromised
- Device Packaging Compromised
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BLADDER EVACUATOR DEVICE WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PACKAGING OF THE DEVICE WAS NOTED TO BE DAMAGED. IT WAS NOTICED THAT THE PACKAGING HAS A CUT. REPORTEDLY, THIS WAS NOT USED IN A PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.