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 2020-03-19 for SYRINGE.VACLOK FIXED MALE LUER CONNECTOR VAC160E manufactured by Merit Medical Systems Inc..
[186553316]
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
[186553317]
The distributor reported a foreign object inside the fluid path of a vac syringe. 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 | 1721504-2020-00019 |
| MDR Report Key | 9857531 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-03-21 |
| Date Added to Maude | 2020-03-19 |
| 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 INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN,, UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE.VACLOK FIXED MALE LUER CONNECTOR |
| Generic Name | VACLOCK SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-13 |
| Catalog Number | VAC160E |
| Lot Number | H1308389 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN,, UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |