MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-07 for 9 LITER ACCESSORY DRAIN BAG (1 SP-418) 6033765 manufactured by Gambro Renal Products.
[1457761]
Nine liter effluent (drainage bag) suddenly burst open at side seam and gushed effluent drainage all over the floor, machine etc. This is second bag in one week. The other bag had leaked at the mid circle seam. We are trying to determine if bag is too full as both occurred at about the full point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1601433 |
| MDR Report Key | 1601433 |
| Date Received | 2010-02-07 |
| Date of Report | 2010-02-07 |
| Date of Event | 2009-12-21 |
| Report Date | 2010-02-07 |
| Date Reported to FDA | 2010-02-07 |
| Date Added to Maude | 2010-02-17 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9 LITER ACCESSORY DRAIN BAG (1 SP-418) |
| Generic Name | BAG, DRAINAGE, CRRT |
| Product Code | FII |
| Date Received | 2010-02-07 |
| Returned To Mfg | 2010-01-06 |
| Model Number | NA |
| Catalog Number | 6033765 |
| Lot Number | NA |
| 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 | 2010-02-07 |