MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-02 for RLV-2100 "B" VACUUM RELIEF VALVE 4103102 manufactured by Quest Medical, Inc..
[34913958]
The foreign distributor reported an issue encountered with the suction valve. They reported that their customer (hospital perfusionist) reported that the valve leaked during use. The valve was returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
[35752989]
The lot number of the device was not provided nor recorded by the user facility. The device was returned to the manufacturer for evaluation. The device was attached to a roller pump and tested at both high and low speeds, but no leaks were observed. The device was tested a various pressure settings of negative and positive pressures and a leak was observed at a positive pressure of 1012mmhg. This device is designed to provide pressure relief at a negative pressure of -200mmhg and at a positive pressure of <1300mmhg. Visually there was dried/crystallized blood found on the umbrella valve edges. The cause of the reported defect could not be determined. The complaint condition could not be duplicated. 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
| Report Number | 1649914-2015-00112 |
| MDR Report Key | 5339684 |
| Date Received | 2016-01-02 |
| Date of Report | 2015-12-23 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2015-12-02 |
| Date Added to Maude | 2016-01-02 |
| 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 | 3 |
| Brand Name | RLV-2100 "B" VACUUM RELIEF VALVE |
| Generic Name | CPBP SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2016-01-02 |
| Returned To Mfg | 2015-12-07 |
| Model Number | 4103102 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-01-02 |