MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for CONN FILTER TO TUBING MEGAVAC 2140J manufactured by Megadyne Medical Products, Inc..
[115771904]
(b)(4). Investigation summary received (b)(4) each of 2140j of lot number 183199. In addition, two photos were returned and reviewed. The investigation confirmed that the product inside of the sealed packages did not match the photo of the packaging. There was no thread on one end of the device and the incorrect type of connector on the other end of the device. This was also confirmed by the two photos returned. A review of the dhr shows this product was originally manufactured to specifications and there is no evidence of device defect or malfunction.
Patient Sequence No: 1, Text Type: N, H10
[115771905]
It was reported that when the customer received their orders for product code 2140j that the pictures on the product labels are correct but the product that is inside the packages is not what they ordered. The adapters are different than the devices they previously ordered under the product code of 2140. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721194-2018-00026 |
| MDR Report Key | 7736983 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-01-03 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2018-05-21 |
| Date Added to Maude | 2018-07-31 |
| 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 | MILT GARRETT |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer G1 | IC MEDICAL INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONN FILTER TO TUBING MEGAVAC |
| Generic Name | CONNECTOR FILTER TO TUBING MEGA VAC |
| Product Code | FYD |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-07-17 |
| Catalog Number | 2140J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84020 US 84020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |