MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-09 for 16F LATEX FOLEY CATHETER DYNDP160116 manufactured by Medline Industries, Inc..
[18546666]
The catheter would not drain, requiring another catheter to be inserted.
Patient Sequence No: 1, Text Type: D, B5
[18865635]
The catheter had been inserted during surgery and saline and methylene blue had been instilled into the patient's bladder. The catheter stopped draining and the clinician was unable to deflate the balloon. They cut the catheter and it began to drain. A new catheter was inserted. No patient injury resulted. The sample was not returned for evaluation. A root cause was not determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00058 |
| MDR Report Key | 3876479 |
| Report Source | 05,06 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-06-05 |
| Date of Event | 2014-04-28 |
| Date Mfgr Received | 2014-05-06 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-06-18 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 16F LATEX FOLEY CATHETER |
| Generic Name | NONE |
| Product Code | NWR |
| Date Received | 2014-06-09 |
| Catalog Number | DYNDP160116 |
| Lot Number | 14MB4215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Required No Informationntervention | 2014-06-09 |