MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for RETROGUARD ARTERIAL SAFETY VALVE 4007200 manufactured by Quest Medical, Inc..
[32090558]
There were no devices returned to the manufacturer for analysis. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition. Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[32090559]
The distributor reported an issue encountered by their customer with the retroguard device. This device is sold non-sterile to the distributor by the manufacturer for further processing. The report stated the duckbill valve in the arterial line came off of the valve and had to be addressed intra-operatively. Follow up on the event found that there was minimal amount of patient blood lost. The report stated the perfusionist reacted quickly and reconnected the tubing to the valve to resume the procedure. There were no patient complications reported as a result of the alleged event. The customer did not keep the device to return to the distributor or the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2015-00099 |
| MDR Report Key | 5240965 |
| Date Received | 2015-11-20 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-07-27 |
| Date Mfgr Received | 2015-10-26 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2015-11-20 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| 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 | CPBP ADAPTER, STOPCOCK, MANIFOLD OR FITTING |
| Product Code | MJJ |
| Date Received | 2015-11-20 |
| Model Number | 4007200 |
| Lot Number | 048243 |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2015-11-20 |