MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-08 for TUBING KIT PM6148/CN manufactured by Merit Medical Systems, Inc.
[46859462]
One device returned for evaluation. The evaluation is in process. A follow up report will be submitted when the evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[46859463]
While preparing for a procedure a breach in the devices packaging was identified. The device was not used on a patient.
Patient Sequence No: 1, Text Type: D, B5
[47545083]
One device returned for evaluation. The package was visually inspected and the clear film of the package was found to be cut. The complaint is confirmed. The root cause was determined to be rough handling of the package. The device history record was reviewed and no exceptions were found. The complaint database was reviewed and found no related complaints for this lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2016-00076 |
| MDR Report Key | 5707732 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-16 |
| Date of Event | 2016-04-12 |
| Date Mfgr Received | 2016-06-07 |
| Device Manufacturer Date | 2013-05-14 |
| Date Added to Maude | 2016-06-08 |
| 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 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 | TUBING KIT |
| Generic Name | TUBING KIT |
| Product Code | DXJ |
| Date Received | 2016-06-08 |
| Returned To Mfg | 2016-05-27 |
| Catalog Number | PM6148/CN |
| Lot Number | H476630 |
| Device Expiration Date | 2016-04-30 |
| 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 | 2016-06-08 |