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 2017-09-21 for HIGH PRESSURE TUBING HPF200E manufactured by Merit Medical Systems, Inc..
[87329668]
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 complaint database was performed and no similar complaints for this lot number were found. A review of the device history record was performed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
[87329669]
The distributor reported a defect in the packaging. 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 | 1721504-2017-00212 |
| MDR Report Key | 6883592 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-09-21 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-04-17 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2017-01-18 |
| Date Added to Maude | 2017-09-21 |
| 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. CASEY HUGHES, MS, CQE, CSQP |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 94095 |
| Manufacturer Country | US |
| Manufacturer Postal | 94095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 94095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH PRESSURE TUBING |
| Generic Name | HIGH PRESSURE TUBING |
| Product Code | DXJ |
| Date Received | 2017-09-21 |
| Returned To Mfg | 2017-09-11 |
| Catalog Number | HPF200E |
| Lot Number | H1074577 |
| 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 94095 US 94095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-21 |