MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-22 for BAG SET, 1200ML, ENFITCONNECTOR INF1200-A manufactured by Moog Medical Devices Group.
[125117798]
The device was not returned to mmdg for evaluation. A dhr was performed and found no non-conformances during the build. Because it was not returned, mmdg has been unable to investigate or confirm the complaint.
Patient Sequence No: 1, Text Type: N, H10
[125117799]
The initial reporter states that the "bags were not working". They stated that the pump was running, but "formula would not go through the bag". Mmdg followed up with the initial reporter, who stated that the patient only received part of their feeding due to the formula not delivering, but that the patient was doing well afterwards, and had not had any adverse effects. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2018-00253 |
| MDR Report Key | 7991769 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-22 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2018-04-26 |
| Date Added to Maude | 2018-10-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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, SRL |
| Manufacturer Street | COYOL FREE ZONE AND BUSINESS PARK |
| Manufacturer City | ALAJUELA, SAN JOSE 20113 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAG SET, 1200ML, ENFITCONNECTOR |
| Generic Name | ENTERAL FEEDING SET |
| Product Code | PIO |
| Date Received | 2018-10-22 |
| Model Number | INF1200-A |
| Catalog Number | INF1200-A |
| Lot Number | CF1811007 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-10-22 |