MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-15 for LATEX FOLEY CATHETER, 14F DYND160214 manufactured by Medline Industries, Inc..
[5146646]
The rn was unable to remove approx 3ml of fluid from the catheter's balloon.
Patient Sequence No: 1, Text Type: D, B5
[12402013]
One to two days post insertion, the rn attempted to remove the foley catheter and the balloon would not fully deflate. She was able to remove 7ml of fluid without issue but was unable to remove the remaining 2-3ml. The catheter was pulled out with a partially inflated balloon intact. The facility reported that no serious injury resulted and no medical intervention was initiated as a result of this incident. The catheter was not replaced. The sample was not returned for eval. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00094 |
| MDR Report Key | 4210068 |
| Report Source | 05,06 |
| Date Received | 2014-10-15 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-06-09 |
| Date Mfgr Received | 2014-09-16 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-10-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2014-10-15 |
| Catalog Number | DYND160214 |
| Lot Number | 14CB9965 |
| 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 | 2014-10-15 |