MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-03-15 for BAG SET, 1200ML, ENFITCONNECTOR INF1200-A manufactured by Moog Medical Devices Group.
[40392872]
The complainant did not return the device for evaluation. A dhr review was performed on lot#cf1517010 no defects were found and no ncrs were issued during the original build.
Patient Sequence No: 1, Text Type: N, H10
[40392873]
The initial reporter stated: bag set stops working, pump shows running but formula will not flow. Sometimes she has to change bags as often as twice before the feeding can be completed" gender of child provided during the conversation, but when asked she would not provide his age, weight or diagnosis - said it was pertinent. Dose and formula were given: 115 ml/hour for a total of 1350 ml of neocate jr power mixed with pedialyte. She threw away the last bag where this occured but said she would send on when it happens again. [complaint-(b)(4)].
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00361 |
| MDR Report Key | 5503116 |
| Report Source | CONSUMER |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2015-10-21 |
| Date Mfgr Received | 2015-10-23 |
| Device Manufacturer Date | 2015-06-19 |
| Date Added to Maude | 2016-03-15 |
| 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 | MR. MATT BRINKERHOFF |
| 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 | 2016-03-15 |
| Model Number | INF1200-A |
| Catalog Number | INF1200-A |
| Lot Number | CF1517010 |
| Device Expiration Date | 2018-06-19 |
| 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 | 2016-03-15 |