MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-23 for FOLEY CATHETER, 16FR SILICONE DYND160816 manufactured by Medline Industries, Inc..
[4625530]
The foley catheter fell out and the balloon was found to be ruptured.
Patient Sequence No: 1, Text Type: D, B5
[11939646]
The catheter fell out and the balloon was found to be ruptured. There was no pt injury and a new catheter was not inserted. No medical intervention was indicated. The sample was returned and evaluated. The balloon had a clean tear. It is not known how much fluid was used to inflate the balloon. We cannot rule out over-inflation of the catheter balloon as a potential root cause for the rupture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00054 |
| MDR Report Key | 3961011 |
| Report Source | 06 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-05-22 |
| Date of Event | 2014-04-22 |
| Date Mfgr Received | 2014-04-23 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-08-04 |
| 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 | FOLEY CATHETER, 16FR SILICONE |
| Product Code | NWR |
| Date Received | 2014-05-23 |
| Catalog Number | DYND160816 |
| Lot Number | 13WB3883 |
| 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 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-23 |