MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-05 for FOLEY CATHETER, 16F DYND160416 manufactured by Medline Industries, Inc..
[4136313]
During a c-section, the catheter fell out and was replaced.
Patient Sequence No: 1, Text Type: D, B5
[11682862]
During a c-section, the foley catheter fell out. The balloon was reported to be deflated but not ruptured. The entire catheter was intact. A new catheter was inserted and no additional intervention was indicated. The sample was not returned for eval. No lot number provided. We have not confirmed the issue or identified a root cause. In the absence of a balloon rupture, it is possible the catheter balloon may not have been sufficiently inflated after it was first inserted into the pt's bladder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00009 |
| MDR Report Key | 3625098 |
| Report Source | 05,06 |
| Date Received | 2014-02-05 |
| Date of Report | 2014-01-30 |
| Date of Event | 2013-12-20 |
| Date Mfgr Received | 2013-12-31 |
| Date Added to Maude | 2014-02-14 |
| 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, 16F |
| Product Code | NWR |
| Date Received | 2014-02-05 |
| Catalog Number | DYND160416 |
| Lot Number | UNK |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-05 |