MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for RETROGUARD ARTERIAL SAFETY VALVE 4007100 manufactured by Quest Medical, Inc.
[131715730]
The alleged incident occurred outside of the us. This medwatch is being submitted because quest distributes a similar device in the us. An investigation will be conducted on the complaint samples and a follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[131715731]
A report was received regarding an alleged issue with the valve. The report states that particulate matter was found in the housing of the valve during circuit assembly. The device was not used on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2018-00100 |
| MDR Report Key | 8200216 |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2018-12-27 |
| 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 | TOSAN ONOSODE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RETROGUARD ARTERIAL SAFETY VALVE |
| Generic Name | CPB CHECK VALVE |
| Product Code | MJJ |
| Date Received | 2018-12-27 |
| Returned To Mfg | 2018-12-20 |
| Model Number | 4007100 |
| Catalog Number | 4007100 |
| Lot Number | 0560968E06 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-27 |