MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-18 for CRRT UF DRAINAGE BAG UNK 72110511 manufactured by B Braun Medical, Inc.
[569315]
Seven liters drainage bag for crrt (continuous renal replacement therapy) machine ruptured at the top where the bag hangs from the machine. Follow-up description or email text: six examples of failed item. Returned to manufacturer via usps for examination and analysis. This follows initial formal report of product complaint. Three unused examples of item from suspect lot forwarded to biomedical engineering for exam/analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 812200 |
| MDR Report Key | 812200 |
| Date Received | 2007-01-18 |
| Date of Report | 2007-01-12 |
| Date of Event | 2006-11-21 |
| Report Date | 2007-01-12 |
| Date Reported to FDA | 2007-01-18 |
| Date Added to Maude | 2007-02-06 |
| 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 |
| 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 | CRRT UF DRAINAGE BAG |
| Generic Name | BAG, DRAINAGE |
| Product Code | FIF |
| Date Received | 2007-01-18 |
| Model Number | UNK |
| Catalog Number | 72110511 |
| Lot Number | 061142 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 799683 |
| Manufacturer | B BRAUN MEDICAL, INC |
| Manufacturer Address | MANUFACTURING DIVISION 901 MARCON BOULEVARD ALLENTOWN PA 18019 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-18 |