MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-03-15 for BAG SET, 500ML, ENFITCONNECTOR INF0500-A manufactured by Moog Medical Devices Group.
[40395215]
The complainant did not return the device for evaluation. As no lot number was provided; a review of the dhr was not possible. Therefore (b)(4) could not verify or investigate the complaint.
Patient Sequence No: 1, Text Type: N, H10
[40395216]
As recorded by customer service: feeding bag filled with 150 ml formula at 0600 and feed ran 147 ml, however, bag was still completely full of formula. Feeding bag replaced and feed appeared to be running correctly when nurse left for shift. Per mother, feeding bag was used less than 24 hours. The initial reporter did not provide lot specific information. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00357 |
| MDR Report Key | 5502956 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-10-08 |
| 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, 500ML, ENFITCONNECTOR |
| Generic Name | ENTERAL FEEDING SET |
| Product Code | PIO |
| Date Received | 2016-03-15 |
| Model Number | INF0500-A |
| Catalog Number | INF0500-A |
| Lot Number | NOT PROVIDED |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 |