MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-30 for KATEX FOLEY CATHETER TRAY, 16F DYND160116 manufactured by Medline Industries, Inc..
[4133074]
The clinician attempted to remove the catheter following a surgical procedure. The balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
[11674450]
The catheter was inserted in the operating room prior to a surgical procedure. Later that day, the clinician was unsuccessful in deflating the balloon in order to remove the catheter. She cut the pigtail on the inflation port and observed some drops of fluid but full deflation was not achieved. The physician attempted to rupture the balloon by inserting a needle but was unsuccessful. During the night, when the patient got up, the catheter fell out on its own. No add'l intervention was necessary. The catheter was returned for evaluation. A visual inspection revealed a deflated balloon and a severed inflation valve. The inflation valve was not returned to us. The catheter balloon was inflated through the inflation lumen with water. The balloon inflated and deflated as intended. The reported issue could not be duplicated with the returned sample. A root was not determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00008 |
| MDR Report Key | 3621483 |
| Report Source | 05,06 |
| Date Received | 2014-01-30 |
| Date of Report | 2014-01-24 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2013-12-26 |
| Date Added to Maude | 2014-02-12 |
| 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 | 3 |
| 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 | KATEX FOLEY CATHETER TRAY, 16F |
| Product Code | NWR |
| Date Received | 2014-01-30 |
| Catalog Number | DYND160116 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-30 |