MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for RETROGUARD ARTERIAL SAFETY VALVE 4007100 manufactured by Quest Medical, Inc.
[94993866]
There was no reported patient complication resulting from the alleged issue. The device will be investigation and a follow-up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[94993867]
A customer reported an issue with the valve. The report states that during a circuit assembling an operator found two of fiberly dusts colored in black in the retroguard housing the retroguard housing. The operator elected not to use the valve for the circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00109 |
| MDR Report Key | 7115416 |
| Date Received | 2017-12-13 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-11-23 |
| Date Mfgr Received | 2017-11-21 |
| Date Added to Maude | 2017-12-13 |
| 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 | 2017-12-13 |
| Returned To Mfg | 2017-12-07 |
| Model Number | 4007100 |
| Catalog Number | 4007100 |
| Lot Number | 0530017F07 |
| Device Availability | R |
| 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 | 2017-12-13 |