MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for RETROGUARD ARTERIAL SAFETY VALVE 4007200 manufactured by Quest Medical, Inc..
[38879405]
Visual examination of the device confirmed there was a significant crack in the housing on one side of the device. In-process inspection of the device during manufacture includes a 100% leak test. It is unlikely the crack occurred at the manufacturer's location. This device is sold non-sterile to the distributor for further processing (packaging/sterilization) prior to shipment to customers. 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
[38879406]
The distributor reported an issue encountered by their customer with the retroguard device. This device is sold non-sterile to the distributor by the manufacture for further processing (packaging/sterilization). The report stated that the issue was found at the hospital by the perfusionist while priming the a-v loop. The perfusionist reported that the retroguard valve leaked, and upon closer inspection they found a crack lengthwise on the valve. There was no blood loss reported because the issue was found during priming (no patient involvement). The device was returned to the distributor and then to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2016-00003 |
| MDR Report Key | 5439642 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-02 |
| Date of Event | 2016-01-29 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2015-04-10 |
| Date Added to Maude | 2016-02-16 |
| 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 | 2016-02-16 |
| Returned To Mfg | 2016-02-04 |
| Model Number | 4007200 |
| Lot Number | 048585 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-02-16 |