MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-27 for LATEX FOLEY CATHETER, 14F DYND160114 manufactured by Medline Industries, Inc..
[5101069]
The balloon would not deflate and was manually ruptured with a needle.
Patient Sequence No: 1, Text Type: D, B5
[12252501]
While attempting to remove the catheter from a labor and delivery pt, the balloon would not deflate. A needle was inserted suprapubically with the aid of ultrasound to manually rupture the balloon. The sample was returned to us in six pieces. Each piece/section of the catheter was tested with air and water for continuous flow. All parts of the catheter allowed for a free flow without any obstruction. The foley balloon inflated and deflated without any issues. The inflation eye was visually inspected. There was no indication that would suggest an obstruction in the eye. There was a large opening in the eye that allowed for water to flow passively through the inflation lumen. Because each piece exhibited continuous flow, a failure indicating a non-deflating balloon was not identified. A root cause for the reported incident was not determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00087 |
| MDR Report Key | 4173273 |
| Report Source | 06 |
| Date Received | 2014-09-27 |
| Date of Report | 2014-09-22 |
| Date of Event | 2014-08-24 |
| Date Mfgr Received | 2014-08-25 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-10-16 |
| 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, 14F |
| Product Code | NWR |
| Date Received | 2014-09-27 |
| Catalog Number | DYND160114 |
| Lot Number | 14QB5250 |
| 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 | 2014-09-27 |