MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for INFINITY 500ML FEEDING BAG SET WITH ENFIT CONNECTOR INF0500-A manufactured by Zevex International, Inc..
[135006137]
The nurse attempted to hang a feeding with the enteralite infinity pump and the bag leaked. She replaced the bag and the second one also leaked at the pump tubing. On a separate occasion a few days earlier, the bag was filled with formula and there was what appeared to be a blackened hole in the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8304588 |
| MDR Report Key | 8304588 |
| Date Received | 2019-02-05 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-27 |
| Report Date | 2018-12-27 |
| Date Reported to FDA | 2018-12-27 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Added to Maude | 2019-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFINITY 500ML FEEDING BAG SET WITH ENFIT CONNECTOR |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2019-02-05 |
| Model Number | INF0500-A |
| Catalog Number | INF0500-A |
| Lot Number | CF1824401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZEVEX INTERNATIONAL, INC. |
| Manufacturer Address | 4314 ZEVEX PARK LN. SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-05 |