MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-15 for FOLEY CATHETER DYND160516 manufactured by Medline Industries, Inc..
[4088441]
A confused and combative pt in the emergency department yanked his indwelling catheter and it broke.
Patient Sequence No: 1, Text Type: D, B5
[11517410]
The foley catheter was inserted into a male pt in the emergency department. He was reported to be disoriented and combative. Moments later he "yanked" on the catheter and it broke, leaving a retained piece in the pt. It was removed via cystoscopy by the urologist three days later. No reported trauma to the pt and no additional intervention was required. The actual sample was not retained for evaluation. We have no info to suggest a manufacturing defect caused or contributed to the reported incident. The incident was determined to be pt caused. Due to the need for surgical intervention, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00006 |
| MDR Report Key | 3608882 |
| Report Source | 05 |
| Date Received | 2014-01-15 |
| Date of Report | 2014-01-17 |
| Date of Event | 2013-12-13 |
| Date Mfgr Received | 2013-12-18 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-02-06 |
| 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 | 3 |
| 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 | FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2014-01-15 |
| Catalog Number | DYND160516 |
| Lot Number | 13KB3848 |
| Operator | LAY USER/PATIENT |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-01-15 |