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 2020-01-22 for CONTROL SYRINGE 00884450011874 CCS600/CNB manufactured by Merit Medical Systems Inc..
[184834167]
The suspect device was not returned for evaluation. The complaint was confirmed through a view of a photograph of the subject device. The root cause could not be determined. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
[186547972]
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186547973]
The account alleges that during preparations for a percutaneous coronary intervention [pci] procedure, a foreign body was identified within the coronary control syringe [ccs]. The ccs was filled saline and inverted to remove all the air from within the syringe when a white foreign body was identified within the barrel. A new ccs was opened and prepped for this procedure. No patient interaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00003 |
| MDR Report Key | 9618616 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2019-12-25 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-27 |
| Date Added to Maude | 2020-01-22 |
| 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 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| 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 | CONTROL SYRINGE |
| Generic Name | SYRINGE |
| Product Code | DXT |
| Date Received | 2020-01-22 |
| Model Number | 00884450011874 |
| Catalog Number | CCS600/CNB |
| Lot Number | H1646933 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |