MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-15 for LATEX FOLEY CATHETER, 16F DYNDP160116 manufactured by Medline Industries, Inc..
[17390023]
The balloon would not deflate and the catheter was removed in interventional radiology.
Patient Sequence No: 1, Text Type: D, B5
[17780978]
Prior to removing the catheter, the balloon would not deflate. The inflation port was cut by the clinician and the balloon did not passively deflate. The catheter was then cut closer to where it exited the pt. When the balloon still did not deflate, the pt was taken to interventional radiology and the balloon was manually ruptured with a needle. The sample was not released for eval. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00069 |
| MDR Report Key | 3952022 |
| Report Source | 05,06 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-07-11 |
| Date of Event | 2014-06-09 |
| Date Mfgr Received | 2014-06-13 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-07-24 |
| 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 | LATEX FOLEY CATHETER, 16F |
| Product Code | NWR |
| Date Received | 2014-07-15 |
| Catalog Number | DYNDP160116 |
| Lot Number | RRIQ |
| 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 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-15 |