MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-11 for SILICONE FOLEY CATHETER, 14F DYND160814 manufactured by Medline Industries, Inc..
[4710423]
The balloon would not inflate and a new catheter was inserted.
Patient Sequence No: 1, Text Type: D, B5
[11983549]
Upon insertion of the foley catheter, the balloon would not inflate. A new catheter was inserted without further incident. No patient injury resulted. The sample was returned and evaluated. The balloon was tested. It inflated normally and deflated passively as intended. However, after approximately 10 seconds, a drop of fluid was noted to leak from the inflation port. The inflation valve did not fully close after the syringe was removed from the port. This is the first reported incident of this nature for this device. A root cause was not determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00068 |
| MDR Report Key | 4008327 |
| Report Source | 06 |
| Date Received | 2014-07-11 |
| Date of Report | 2014-07-10 |
| Date of Event | 2014-06-01 |
| Date Mfgr Received | 2014-06-11 |
| Date Added to Maude | 2014-08-26 |
| 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 | 0 |
| 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 | SILICONE FOLEY CATHETER, 14F |
| Product Code | NWR |
| Date Received | 2014-07-11 |
| Catalog Number | DYND160814 |
| 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 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-11 |