MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-15 for LATEX FOLEY CATHETER, 16F DYND160116 manufactured by Medline Industries, Inc..
[19086255]
The balloon would not deflate and was manually ruptured by the physician.
Patient Sequence No: 1, Text Type: D, B5
[19097094]
Several days following a uro/gyne surgery, when attempting to remove the foley catheter, the balloon would not deflate. The staff cut the inflation pigtail, but the balloon would not passively deflate. The patient was taken to the operating room and under light sedation, the balloon was manually ruptured with a needle. Following a second surgery that was unrelated to this incident, this same patient had a similar issue. Again, when attempting to remove the catheter, the balloon would not deflate. This time, the surgeon removed the catheter in his office utilizing the same technique. He stated there was no injury to the patient for either incident. Two samples were returned and evaluated. Clamp marks located below the inflation port bifurcation were visually apparent on both catheters. The inflation lumen on one catheter was found to be fully compressed at the location of the clamp mark. This obstruction would not allow for fluid or air to pass and this was determined to be the root cause for the non-deflation of the balloon. The second catheter was slightly compressed at the location of the clamp marks, but not fully occluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00077 |
| MDR Report Key | 4036252 |
| Report Source | 05 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2014-07-15 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-08-27 |
| 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 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 | 2014-08-15 |
| Catalog Number | DYND160116 |
| Lot Number | 13JB3557 |
| 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 | 2014-08-15 |