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 2016-07-21 for MERIT HIGH PRESSURE TUBING HPT480E manufactured by Merit Medical Systems, Inc.
[50188923]
One device was returned for evaluation. The investigation is still in progress. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[50188924]
A tear was found in the clear film of the packaging. This was found during the distributor's incoming inspection. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5
[51134042]
One device was returned for evaluation. The device was examined visually and a hole was found in the clear film. The complaint is confirmed. The root cause is attributed to rough handling during inspection. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2016-00125 |
| MDR Report Key | 5813821 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-04-14 |
| Date Mfgr Received | 2016-07-26 |
| Device Manufacturer Date | 2016-01-25 |
| Date Added to Maude | 2016-07-21 |
| 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. JERRY MCPHIE |
| Manufacturer Street | 1600 WEST MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084491 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC |
| Manufacturer Street | 1600 WEST 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 HIGH PRESSURE TUBING |
| Generic Name | HIGH PRESSURE TUBING |
| Product Code | DXJ |
| Date Received | 2016-07-21 |
| Returned To Mfg | 2016-07-15 |
| Catalog Number | HPT480E |
| Lot Number | H898262 |
| Device Expiration Date | 2018-12-31 |
| 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 WEST MERIT PARKWAY SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-21 |