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..
[53695152]
Patient Sequence No: 1, Text Type: N, H10
[53695153]
An elderly female was admitted from ed to a medical bed. A urinary catheter was placed a few days after admission. After the catheter was placed, she developed increasing oxygen needs and was transferred to the icu after receiving several doses of lasix. Her urine output was noted to be decreased once in icu. Nursing noted the catheter to be out of the patient body with balloon intact, inflated at 7cc. These catheters are replacements at our facility while our standard urinary catheter is backordered. A new catheter was inserted. Other such incidents have been reported anecdotally. I 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 | 5920472 |
| MDR Report Key | 5920472 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-07-24 |
| 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 | NGAT0207 |
| 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 |