MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-09 for LATEX FOLEY CATHETER TRAY, 14F DYND160214 manufactured by Medline Industries, Inc..
[4683620]
The balloon catheter would not deflate and required a urology consult for removal.
Patient Sequence No: 1, Text Type: D, B5
[12161860]
The risk manager reported that following a c-section, they attempted to remove the foley catheter but the balloon would not deflate. It required a urology consult for removal. The risk manager stated she would not disclose any other info pertaining to the incident. The sample was retained by the facility. It was contained in a bag. They allowed it to be viewed while in the bag but they would not allow it to be touched or manipulated in any way. A root cause was not able to be determined. We were not made aware of any injury resulting from this incident. It is not known what intervention was required to deflate the balloon.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00047 |
| MDR Report Key | 3854013 |
| Report Source | 05,06 |
| Date Received | 2014-05-09 |
| Date of Report | 2014-05-08 |
| Date of Event | 2014-01-21 |
| Date Mfgr Received | 2014-04-09 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-06-09 |
| 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 | 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 | LATEX FOLEY CATHETER TRAY, 14F |
| Product Code | NWR |
| Date Received | 2014-05-09 |
| Catalog Number | DYND160214 |
| Lot Number | 13UB1428 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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; 2. Required No Informationntervention | 2014-05-09 |