MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-27 for FOLEY CATHETER TRAY, 14F DYND160114 manufactured by Medline Industries, Inc..
[4038791]
The balloon would not deflate and was manually ruptured by the physician with the aid of a guidewire.
Patient Sequence No: 1, Text Type: D, B5
[11330504]
It was reported that the balloon would not deflate as the clinician was attempting to remove the foley catheter. The urologist manually ruptured the balloon with the aid of a guidewire. The catheter was then easily removed, intact, without further incident. The facility reported that they did not retain the sample for evaluation and they were unable to provide us with a lot number. A root cause has not been determined. Due to the reported incident and need for intervention, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00090 |
| MDR Report Key | 3497317 |
| Report Source | 05,06 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-10-18 |
| Date Mfgr Received | 2013-10-25 |
| Date Added to Maude | 2013-12-04 |
| 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 | 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 TRAY, 14F |
| Product Code | NWR |
| Date Received | 2013-11-27 |
| Catalog Number | DYND160114 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-27 |