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..
[115778383]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[115778384]
It was reported that part number 2140j was ordered and this was the part number on the box but the part inside the box was not what had been ordered. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721194-2018-00024 |
| MDR Report Key | 7736530 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-07-02 |
| 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 | 0 |
| 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. 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 | 2018-09-25 |
| Catalog Number | 2140J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84020 US 84020 |
| 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 | 2018-09-25 |
| Catalog Number | 2140J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |