MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-26 for ERASE CAUTI * manufactured by Medline Industries, Inc..
[4187048]
Foley will not deflate. ====================== manufacturer response for foley catheter, medline (per site reporter). ======================1. It sounds to him as if the inflation valve is not engaging, so he asked that they really push the syringe (or pull another syringe) into the valve to ensure that its engaging properly. Once they do this and get the valve to engage, then allow the balloon to passively deflate. 2. If that doesn't work, cut the catheter just above the inflation valve, like right where the shrink wrap is around the valve. See if it drains, and if it doesn't, attach a syringe to the opening and pull back. 3. If that doesn't work, cut the inflation lumen right by the y-junction. You'll see two lumens, the smaller one is the inflation lumen. Use a 16 or 18 gauge needle in the small lumen and a syringe at the end to suck the water out of the balloon. This can be done at the bedside. 4. If all of the above do not work, its likely necessary to call the urologist. 5. Use a guide wire to go up into the inflation lumen and pop the balloon. This can be done at the bedside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3590800 |
| MDR Report Key | 3590800 |
| Date Received | 2013-11-26 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-11-25 |
| Report Date | 2013-11-26 |
| Date Reported to FDA | 2013-11-26 |
| Date Reported to Mfgr | 2014-01-24 |
| Date Added to Maude | 2014-01-24 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERASE CAUTI |
| Generic Name | FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2013-11-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | QUKP |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-26 |