MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-04 for FOLEY CATHETER UNK manufactured by Medline Industries, Inc..
[4462783]
While performing peri-care, the catheter fell out and was replaced.
Patient Sequence No: 1, Text Type: D, B5
[12119965]
While providing peri care to a pt, the foley came out. The balloon was not inflated and the contact at the facility commented that she did not know if the balloon had been inflated when the catheter was initially inserted in the emergency room. No damage was noted to the catheter or the balloon. They attempted to inflate the balloon after it fell out but were not successful. The sample was not retained for evaluation. We have no item number or lot number. No photos were provided. They replaced the catheter and reported that no pt injury resulted from this incident. We have not identified a root cause. However, in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00057 |
| MDR Report Key | 3862974 |
| Report Source | 05,06 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-05-01 |
| Date Added to Maude | 2014-06-12 |
| 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 | 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 | FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2014-06-04 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2014-06-04 |