MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-13 for BAG SET, 1200ML, ENFITCONNECTOR INF1200-A manufactured by Moog Medical Devices Group.
[174945106]
The device was not returned to mmdg for evaluation. A dhr could not be performed because no lot number was provided. Because the device was not returned, mmdg has been unable to investigate or confirm the complaint. This report will be updated if the device is returned to mmdg.
Patient Sequence No: 1, Text Type: N, H10
[174945107]
The initial reporter states that the pump roller seems to be working but the bag doesn't deliver formula. They also stated that "when they set up a new bag at night that it works, but after rinsing out the bag in the morning it doesn't deliver". They also stated that they are using kate farms formula. Mmdg followed up with the initial reporter, who stated 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 | 1722139-2020-00013 |
| MDR Report Key | 9581901 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| 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, 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 | 2020-01-13 |
| Model Number | INF1200-A |
| Catalog Number | INF1200-A |
| Lot Number | NOT PROVIDED |
| 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 | 2020-01-13 |