MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-12-13 for MERIT CUSTOM KIT K12-YP060A manufactured by Merit Medical Systems, Inc..
[186542824]
The suspect device has been returned for evaluation. The complaint is confirmed. The root cause is attributed to the manufacturing process. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
[186542825]
The distributor alleged that a foreign object was found inside the fluid path within their kit. This was identified during their initial inspection of received product. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2019-00101 |
| MDR Report Key | 9469412 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-12-13 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2019-11-18 |
| Device Manufacturer Date | 2019-09-05 |
| Date Added to Maude | 2019-12-13 |
| 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. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIT CUSTOM KIT |
| Generic Name | CUSTOM KIT |
| Product Code | OEQ |
| Date Received | 2019-12-13 |
| Returned To Mfg | 2019-12-02 |
| Catalog Number | K12-YP060A |
| Lot Number | H1660458 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-13 |