MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-28 for LATEX FOLEY CATHETER KIT, 16F DYND160216 manufactured by Medline Industries, Inc..
[4466396]
The rn had difficulty removing the foley catheter and found that the balloon had approximately 2ml of fluid remaining in it.
Patient Sequence No: 1, Text Type: D, B5
[11837588]
The rn had difficulty removing the catheter following a vaginal delivery. The physician pulled on the catheter and it came out without injury to the patient. It was noted that approximately 2ml of fluid remained in the balloon. The balloon was intact. The sample was not returned for evaluation. We have not confirmed the issue or identified a root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00037 |
| MDR Report Key | 3753394 |
| Report Source | 05,06 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-03-26 |
| Date of Event | 2013-12-14 |
| Date Mfgr Received | 2014-02-28 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-04-17 |
| 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 KIT, 16F |
| Product Code | NWR |
| Date Received | 2014-03-28 |
| Catalog Number | DYND160216 |
| Lot Number | 13UB0208 |
| 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 | 2014-03-28 |