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 2020-03-06 for HIGH PRESSURE TUBING KIT K04-MK2081 manufactured by Merit Medical Systems Mexico.
[185607614]
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
[185607615]
The distributor alleged a defect in the packaging was found 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 | 3011642792-2020-00005 |
| MDR Report Key | 9799453 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-10-11 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-03-27 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS MEXICO |
| Manufacturer Street | 8830 SIEMPRE VIVA RD #100 |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH PRESSURE TUBING KIT |
| Generic Name | EXTENSION TUBING SET |
| Product Code | OJA |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-03 |
| Catalog Number | K04-MK2081 |
| Lot Number | I1535010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS MEXICO |
| Manufacturer Address | 8830 SIEMPRE VIVA RD #100 SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |