MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-01 for FOLEY CATHETER TRAY DYND160216S manufactured by Medline Industries, Inc..
[3787687]
The balloon on the foley catheter would not deflate and was removed in the operating room.
Patient Sequence No: 1, Text Type: D, B5
[11240516]
Two to three days following a vaginal delivery, the clinician attempted to remove the foley catheter. She was unable to withdraw fluid from the port and the balloon would not deflate. After cutting the catheter and also attempting to deflate the balloon with a syringe, they were still unsuccessful. They later took the pt to the operating room and removed it under light sedation. The actual sample was not returned for evaluation. The facility returned two unused samples from two different lots. The actual lot number of the sample involved in the incident is not known. Both samples were evaluated. The balloons were inflated with 10 ml of water without any issues. Upon insertion of a syringe into the inflation port, the balloons passively deflated without issue. Due to the fact that the original sample was not received and the issue could not be confirmed with the two returned samples, a root cause could not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00083 |
| MDR Report Key | 3449026 |
| Report Source | 05,06 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-10-25 |
| Date of Event | 2013-09-28 |
| Date Mfgr Received | 2013-09-30 |
| Date Added to Maude | 2013-11-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 TRAY |
| Product Code | NWR |
| Date Received | 2013-11-01 |
| Catalog Number | DYND160216S |
| 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; 2. Required No Informationntervention | 2013-11-01 |