MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-10 for FOLEY CATHETER TRAY, 16F DYND160116 manufactured by Medline Industries, Inc..
[5103453]
The balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
[12518031]
Following the transvaginal ultrasound, when attempting to remove the foley catheter, the balloon would not deflate. The urologist performed a cystoscopy, inserted a guidewire into the inflation lumen of the catheter and ruptured the balloon. The catheter was then removed. The facility reported that no patient injury resulted and no further intervention was indicated. The catheter was returned for evaluation and was missing the injection arm of the catheter. It had a guidewire inserted into the inflation lumen. The balloon was not completely deflated and contained approximately 2-3 ml of fluid. Upon removal of the guidewire, the balloon did not passively deflate. Upon inspection, the inflated eye was found to be occluded and the eye slit was collapsed. The issue was confirmed with the returned sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00102 |
| MDR Report Key | 4258822 |
| Report Source | 05,06 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-11-05 |
| Date of Event | 2014-10-05 |
| Date Mfgr Received | 2014-10-08 |
| Date Added to Maude | 2014-11-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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, 16F |
| Product Code | NWR |
| Date Received | 2014-11-10 |
| 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 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-10 |