MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-03-15 for BAG SET, 1200ML, ENFITCONNECTOR INF1200-A manufactured by Moog Medical Devices Group.
[40391054]
The complainant did not return the device for evaluation. A dhr review was performed on lot#cf1518410 no defects were found and no ncrs were issued during the original build.
Patient Sequence No: 1, Text Type: N, H10
[40391055]
The initial reporter stated: customer states: problem with bag set returning 1 ea. Lot #cf1518410" said the bag had a kink and there was a mess, while they were cleaning up they had placed a clamp on the tubing, afterwards they forgot to remove the clamp that was placed below the pump on the tubing. After restarting the pump it did not alarm no flow out and continued to run with no food being delivered. At first they thought it was the pump but they took the bag and placed it on another pump to test if it was bag or pump, the same thing occurred on 2nd pump. First pump sn (b)(4) second pump sn (b)(4). After changing bag they wanted to check pumps again so they clamped it above the pump on the tubing and the pumps alarmed no flow in or no food as expected. The reporter did not provide lot specific information. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00362 |
| MDR Report Key | 5503115 |
| Report Source | OTHER |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2015-10-06 |
| Device Manufacturer Date | 2015-07-03 |
| 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 | CF1518410 |
| Device Expiration Date | 2018-07-03 |
| 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 |