MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-08 for LUBRICATH A800361 manufactured by Cr Bard.
[54204397]
Patient Sequence No: 1, Text Type: N, H10
[54204398]
Foley catheter inserted per order, urine immediately starting leaking from connection between 16fr catheter and bag. Leaking bag removed and replaced by another bag. Additionally, l&d unit had three other foley tray kits leak at the catheter insert. Manufacturer response for urinary catheter, (brand not provided) (per site reporter): submitting the issue to bard field assurance and someone will be in touch. Red-bag, pre-paid shipping label and return box being sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5935658 |
| MDR Report Key | 5935658 |
| Date Received | 2016-09-08 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-08-18 |
| Report Date | 2016-08-26 |
| Date Reported to FDA | 2016-08-26 |
| Date Reported to Mfgr | 2016-08-26 |
| Date Added to Maude | 2016-09-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUBRICATH |
| Generic Name | CATHETER, URINARY, KIT |
| Product Code | NWR |
| Date Received | 2016-09-08 |
| Catalog Number | A800361 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CR BARD |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-08 |