MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for RETROGUARD ARTERIAL SAFETY VALVE 4007100 manufactured by Quest Medical, Inc.
[93688970]
The device was not returned for investigation. A follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[93688971]
A customer reported an issue with the valve. The report states that while priming, the medical staff found a particulate matter colored in black in the valve. The length of the particulate matter is about 2mm (about 0. 3mm? ).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00100 |
| MDR Report Key | 7064302 |
| Date Received | 2017-11-28 |
| Date of Report | 2018-01-17 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2017-11-28 |
| 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 | 2017-11-28 |
| Model Number | 4007100 |
| Catalog Number | 4007100 |
| Lot Number | 0521126S05 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-28 |