MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-03-15 for BAG SET, 500ML, ENFITCONNECTOR INF0500-A manufactured by Moog Medical Devices Group.
[40395425]
The complainant did not return the device for investigation. A review of the dhr was performed and no non-conformances were issued during the original build.
Patient Sequence No: 1, Text Type: N, H10
[40395426]
Customer states: family/nursing have delivered mixture of water, elecare jr. And green beans for years same recipe, rate, etc without issues. Nurse reports recently, the teal portion of the tubing is becoming clogged. Nursing has been pulling the tubing off the cassette, cleaning and reattaching. The nurse feels that something has changed inside the tubing as this has happened frequently over the past week. She also notes that they received feeding bags, however unsure if these are the new or old bags. Nurse also reports they are no longer receiving "no flow out alarms" when the tubing is plugged. Pump was exchanged but nurse manager could not duplicate issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00368 |
| MDR Report Key | 5503119 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2015-08-30 |
| Date Mfgr Received | 2015-09-21 |
| Device Manufacturer Date | 2015-05-29 |
| 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 | CF1514906 |
| Device Expiration Date | 2018-05-29 |
| Operator | OTHER CAREGIVERS |
| 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 |