MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-26 for INFINITY BAG SET WITH ENFIT CONNECTOR NOT PROVIDED manufactured by Moog Medical Devices Group.
[81143427]
(b)(4) has attempted to follow up with the initial reporter to obtain the bag that malfunctioned. It is still unclear if (b)(4) will receive the affected set back for investigation. Because it has not been returned at this time, (b)(4) has been unable to investigate or confirm the complaint.
Patient Sequence No: 1, Text Type: N, H10
[81143428]
The initial reporter states that the "bag does not deliver food; pump doesn't alarm. " (b)(4) made multiple attempts to obtain more information and have the set returned for investigation, however, these attempts were unsuccessful. There have been no adverse effects reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2017-00104 |
| MDR Report Key | 6744019 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-26 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-07-26 |
| 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, 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 | INFINITY BAG SET WITH ENFIT CONNECTOR |
| Generic Name | ENTERAL FEEDING SET |
| Product Code | PIO |
| Date Received | 2017-07-26 |
| Model Number | NOT PROVIDED |
| Catalog Number | NOT PROVIDED |
| 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 | 2017-07-26 |