MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for LUBRI-SIL 903216 manufactured by C.r. Bard, Inc..
[53725269]
Patient Sequence No: 1, Text Type: N, H10
[53725270]
A previously placed urinary catheter fell out of a sedated male patient in the icu. The catheter had been inserted the day before in the ed when the pt was intubated nasally for angio-edema. When the icu nurse checked the catheter that came out of the patient, she found that the balloon did inflate. The nurse believes that the balloon must have been must inflated because there was some water in the balloon when inflated with air. A new catheter was inserted. We used this substitute product for about two weeks. We have used about 20 kits. They were stored in the clean supply room as well as in the stat-room on the second floor. Other such incidents have been reported anecdotally. We have not been able to confirm any details of a 3rd and possibly 4th such event, but this is a recurring problem at our facility with these replacement catheters. Manufacturer response for urinary catheter, tray foley 16fr w/urimeter (per site reporter): the company has asked for additional information and i will contact them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5920477 |
| MDR Report Key | 5920477 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-25 |
| Date of Event | 2012-07-24 |
| Report Date | 2016-08-25 |
| Date Reported to FDA | 2016-08-25 |
| Date Reported to Mfgr | 2016-08-25 |
| Date Added to Maude | 2016-09-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | LUBRI-SIL |
| Generic Name | CATHETER, RETENTION TYPE, BALLOON |
| Product Code | EZK |
| Date Received | 2016-09-01 |
| Catalog Number | 903216 |
| Lot Number | NGAS1472 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 428 POWERHOUSE RD MONCKS CORNER SC 29461 US 29461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-01 |