MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-26 for ENTERALITE INFINITY ENTERAL BAG SET WITH ENFIT CONNECTOR INF0500-A manufactured by Moog Medical Devices Group.
[90874055]
The device was returned to mmdg for evaluation. The investigation is still in progress. This report is being filed because the device was in use with a pediatric patient at the time of an over run event, and all such events involving pediatric patients are mdr reportable per our procedure.
Patient Sequence No: 1, Text Type: N, H10
[90874056]
The initial reporter states that the bag set was in use with a pump that was pumping air into the patient. Mmdg followed up with the initial reporter. They stated that the patient was "just fine" and that there had been no delay in therapy or adverse effects from the complaint event. [(b)(4)].
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2017-00158 |
| MDR Report Key | 6980581 |
| Report Source | CONSUMER |
| Date Received | 2017-10-26 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2017-05-15 |
| Date Added to Maude | 2017-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN HARDESTY |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012641001 |
| Manufacturer G1 | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERALITE INFINITY ENTERAL BAG SET WITH ENFIT CONNECTOR |
| Generic Name | ENTERAL FEEDING SETS |
| Product Code | PIO |
| Date Received | 2017-10-26 |
| Returned To Mfg | 2017-10-20 |
| Model Number | INF0500-A |
| Catalog Number | INF0500-A |
| Lot Number | CF1713203 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Address | 4314 ZEVEX PARK LANE SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |