MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-10 for 5 LITER ACCESSORY DRAIN BAG * 114423 manufactured by Gambro-renal Products.
[3100968]
Ultrafiltrate (uf) drain bag for crrt (continuous renal replacement therapy) produced a leak at area of previous fold for packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2886107 |
| MDR Report Key | 2886107 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-12-10 |
| Date of Event | 2012-10-10 |
| Report Date | 2012-12-10 |
| Date Reported to FDA | 2012-12-10 |
| Date Added to Maude | 2012-12-26 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | 5 LITER ACCESSORY DRAIN BAG |
| Generic Name | BAG, DRAINAGE, CRRT |
| Product Code | FII |
| Date Received | 2012-12-10 |
| Returned To Mfg | 2012-10-17 |
| Model Number | * |
| Catalog Number | 114423 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO-RENAL PRODUCTS |
| Manufacturer Address | 14143 DENVER WEST PARKWAY SUITE 400 LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-10 |