MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-03-16 for BAG SET, 1200ML, ENFITCONNECTOR INF1200-A manufactured by Moog Medical Devices Group.
[40411268]
The complainant did not return the device for evaluation. A dhr review was performed on lot #cf1513509 no ncrs were issued during the original build.
Patient Sequence No: 1, Text Type: N, H10
[40411269]
The initial reporter stated: feeding bag full of formula when nurse arrived in the morning indicating patient did not receive overnight enteral feedings. Pump stated all feedings were given. A brand new pump was delivered to the home on monday, (b)(4) 2015. On afternoon of (b)(6) 2015, noted feedings had not infused after 4 hours when initially started and had to remove white transition piece to prime feeding bag and then reconnect to extension to start feeding. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00360 |
| MDR Report Key | 5503639 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-03-16 |
| Date of Report | 2016-03-15 |
| Date of Event | 2015-08-12 |
| Date Mfgr Received | 2015-10-08 |
| Device Manufacturer Date | 2015-05-15 |
| Date Added to Maude | 2016-03-16 |
| 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 | 2016-03-16 |
| Model Number | INF1200-A |
| Catalog Number | INF1200-A |
| Lot Number | CF1513509 |
| Device Expiration Date | 2018-05-15 |
| Operator | NURSE |
| 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 | 2016-03-16 |