MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-19 for LATEX FOLEY CATHETER, 14F DYND160114 manufactured by Medline Industries, Inc..
[15998244]
The balloon would not deflate and was manually ruptured with a needle.
Patient Sequence No: 1, Text Type: D, B5
[16211994]
While attempting to remove the catheter from a labor and delivery patient, 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 three pieces. The section of the catheter containing the balloon had a bed sheet clamp clamped onto it approximately 15cm from the tip. Visually, there was a deep indentation on the catheter near the bifurcation that resulted in a complete occlusion of the inflation lumen. The facility had tested the balloon prior to insertion and had no difficulty inflating the balloon. The indentation and subsequent lumen occlusion was most likely the result of an external force on the catheter and would have occurred post insertion. The source of the external force was not determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00085 |
| MDR Report Key | 4136356 |
| Report Source | 06 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-08-18 |
| Date Mfgr Received | 2014-08-18 |
| Device Manufacturer Date | 2014-03-01 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX FOLEY CATHETER, 14F |
| Product Code | NWR |
| Date Received | 2014-09-19 |
| 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 | 2014-09-19 |