MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-04 for EZ LOK * manufactured by Bard Medical.
[5796185]
Pt has foley catheter that came from surgery two days ago. Foley connected to foley bag with urometer chamber on front of bag. When emptying urometer chamber into posterior bag to empty, urine was noted dripping out of back of bag. When bag inspected 2 punch holes noted that are open to the bag so the foley system was not a closed system. Bag removed from foley catheter and new foley bag applied. Physician's assistant notified and cath urine sent for ua and reflex culture. ======================manufacturer response for bard foley catheter bag, (brand not provided) (per site reporter). ======================we notified the bard rep and he plans to pick up the foley catheter bag for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4767856 |
| MDR Report Key | 4767856 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-04-29 |
| Report Date | 2015-05-04 |
| Date Reported to FDA | 2015-05-04 |
| Date Reported to Mfgr | 2015-05-13 |
| Date Added to Maude | 2015-05-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ LOK |
| Generic Name | URINE COLLECTION BAG |
| Product Code | FAQ |
| Date Received | 2015-05-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 2 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD MEDICAL |
| Manufacturer Address | 730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-04 |