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 2017-02-02 for HIGH PRESSURE TUBING HP9201E manufactured by Merit Medical Systems Inc.
[66459930]
One device has been returned for evaluation. The device was visually examined. The complaint is confirmed. The root cause is attributed to the manufacturing process. The device history record was reviewed and no exception documents were found. The complaint database was reviewed and no similar complaints for this lot number were found. Corrective actions are in process.
Patient Sequence No: 1, Text Type: N, H10
[66459931]
The distributor alleged a defect in the packaging while prepping for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2017-00031 |
| MDR Report Key | 6298884 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-02-02 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-09-23 |
| Date Mfgr Received | 2017-01-25 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2017-02-02 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR CASEY HUGHES MS, CQE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8013164932 |
| 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 | HIGH PRESSURE TUBING |
| Generic Name | HIGH PRESSURE TUBING |
| Product Code | DXJ |
| Date Received | 2017-02-02 |
| Returned To Mfg | 2016-10-31 |
| Catalog Number | HP9201E |
| Lot Number | H847416 |
| Device Expiration Date | 2018-09-30 |
| 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 | 2017-02-02 |