MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for OPEN-END FLEXI-TIP URETERAL CATHETER 021305 manufactured by Cook Inc.
[105518610]
This mdr is being filed after the associated complaint was reviewed under remediation protocol capa (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[105518631]
It was reported that the open-end flexi-tip ureteral catheter broke in half when the tech removed it from the package. This device did not make patient contact, and the procedure was performed with another device. There was no impact to the patient or users.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1820334-2018-01120 |
MDR Report Key | 7422485 |
Date Received | 2018-04-11 |
Date of Report | 2018-04-11 |
Date of Event | 2016-03-15 |
Date Mfgr Received | 2018-04-09 |
Device Manufacturer Date | 2016-07-18 |
Date Added to Maude | 2018-04-11 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. LARRY POOL |
Manufacturer Street | 750 DANIELS WAY |
Manufacturer City | BLOOMINGTON IN 47404 |
Manufacturer Country | US |
Manufacturer Postal | 47404 |
Manufacturer Phone | 8128294891 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | OPEN-END FLEXI-TIP URETERAL CATHETER |
Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
Product Code | GBL |
Date Received | 2018-04-11 |
Catalog Number | 021305 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COOK INC |
Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-04-11 |