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 2019-04-29 for MERIT CUSTOM KIT K09-MS3186 manufactured by Merit Medical Systems Inc..
[143431503]
The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[143431504]
The distributor alleged that a foreign object was found inside the manifold of their custom kit. This was identified upon initial inspection of received product. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5
[144793364]
The suspect device was returned for evaluation. The device was examined visually. The complaint is confirmed. The root cause is attributed to the manufacturing process. A review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and no similar complaints for this lot number were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2019-00029 |
| MDR Report Key | 8560891 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2019-01-11 |
| Date Added to Maude | 2019-04-29 |
| 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 | MRS. KATIE SWENSON CQE,CBA,CQPA. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012531600 |
| 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 | OEZ |
| Date Received | 2019-04-29 |
| Returned To Mfg | 2019-04-15 |
| Catalog Number | K09-MS3186 |
| Lot Number | H1497187 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-29 |