MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-08 for FLEXIFLO ENTERAL NUTRITION FEEDING BAG 56 manufactured by Ross Product Div. Abbott Laboratories.
[21496]
At time of tube feeding administration, it was noted that feeding bag was missing a "roller" on the clamp. Bag removed. No harm/injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007903 |
| MDR Report Key | 28593 |
| Date Received | 1995-12-08 |
| Date of Report | 1995-11-29 |
| Date of Event | 1995-11-16 |
| Date Added to Maude | 1995-12-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIFLO ENTERAL NUTRITION FEEDING BAG |
| Generic Name | FEEDING BAG |
| Product Code | LEY |
| Date Received | 1995-12-08 |
| Catalog Number | 56 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29548 |
| Manufacturer | ROSS PRODUCT DIV. ABBOTT LABORATORIES |
| Manufacturer Address | ABBOTT PARK IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-08 |