MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-22 for LATEX FOLEY CATHETER, 16F DYND160216 manufactured by Medline Industries, Inc..
[4913719]
The balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
[12236356]
The catheter had been inserted for a cystogram. Upon completion of the procedure, they were unable to deflate the balloon to remove the catheter. The pigtail was cut and the balloon did not deflate. They inserted a guidewire into the opening of the inflation lumen and the balloon deflated. The catheter was removed without further incident. No serious injury was resulted and no additional intervention was necessary. The nurse manager indicated that at the time of the incident, the clinician was using a syringe to forceably attempt to aspirate the fluid from the balloon. A root cause was not determined, but it is possible that this force could have caused the lumen to collapse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00086 |
| MDR Report Key | 4136367 |
| Report Source | 05,06 |
| Date Received | 2014-09-22 |
| Date of Report | 2014-09-18 |
| Date of Event | 2014-08-19 |
| Date Mfgr Received | 2014-08-19 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-10-03 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX FOLEY CATHETER, 16F |
| Product Code | NWR |
| Date Received | 2014-09-22 |
| Catalog Number | DYND160216 |
| Lot Number | 13JB0327 |
| 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. Other; 2. Required No Informationntervention | 2014-09-22 |