MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-29 for RLV-2100 VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..
[71206095]
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
[71206096]
The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device. The report stated the device leaked from the red vent line of the distributor's custom perfusion pack. The report stated the leak was monitored and the procedure successfully completed with no complications. There were no patient complications reported as a result of the alleged event. The distributor's performance analysis stated their analysis of the device found it leaked at approximately 600 mmhg instead of the specified 1300 mmhg. The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00022 |
| MDR Report Key | 6445082 |
| Date Received | 2017-03-29 |
| Date of Report | 2017-02-27 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2017-02-27 |
| Device Manufacturer Date | 2016-02-29 |
| Date Added to Maude | 2017-03-29 |
| 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 | RLV-2100 VACUUM RELIEF VALVE |
| Generic Name | CARDIOPULMONARY SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2017-03-29 |
| Returned To Mfg | 2017-02-28 |
| Model Number | 4103202 |
| Lot Number | 050848 |
| 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 | 2017-03-29 |