MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-14 for LATEX FOLEY CATHETER, 16F DYND160116 manufactured by Medline Industries, Inc..
[20974094]
After the catheter was inserted, the balloon would not inflate. A new catheter was inserted.
Patient Sequence No: 1, Text Type: D, B5
[21376374]
During a gyne procedure, after the foley catheter was inserted, the balloon would not inflate and the catheter was replaced. There was no injury to the pt. The facility reported that as they attempted to inflate the balloon with fluid, they visualized a balloon shaped protrusion distal to the y-junction of the catheter. Fluid was allowed to pass through the inflation valve and into the inflation lumen. We have no sample to evaluate. A definitive root cause was not determined but based on the info provided, it appears that the inflation valve functioned properly and flow was then obstructed at the bifurcation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00093 |
| MDR Report Key | 4194086 |
| Report Source | 05,06 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-10-06 |
| Date of Event | 2014-09-09 |
| Date Mfgr Received | 2014-09-09 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-10-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX FOLEY CATHETER, 16F |
| Product Code | NWR |
| Date Received | 2014-10-14 |
| Catalog Number | DYND160116 |
| Lot Number | 13CB2526A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-14 |