MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-05-19 for RLV-2100B 4103202 manufactured by Quest Medical, Inc..
[18092556]
The international distributor (b)(4) reported an issue their customers encountered related to the suction control valve. This valve is provided by the manufacturer as an oem device for further processing/kitting by the distributor. The report stated there were several incidents that occurred at separate hospitals. The distributor received information that during priming of the circuit, when the plasmalyte bag was spiked a leak was observed from the one-way pressure valve. It was reported that the customer waited to see if the leak was only temporary; however, following priming the valve was observed to be continually leaking at about 1 drop/second. As a result of the event the hospital staff changed out the valve. It is unknown if all the valves will be returned to the manufacturer for analysis. There were no patient complications reported as a result of the alleged event. Reference manufacturer reports: 1649914-2015-00017 through 1649914-2015-00022.
Patient Sequence No: 1, Text Type: D, B5
[18445632]
It is unknown if a sample is available to be returned to the manufacturer for analysis. However, the root cause for the same complaint condition has been identified and is currently being addressed in the capa system. 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
| Report Number | 1649914-2015-00029 |
| MDR Report Key | 4781873 |
| Report Source | 01,08 |
| Date Received | 2015-05-19 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-04-20 |
| Device Manufacturer Date | 2014-10-29 |
| Date Added to Maude | 2015-06-17 |
| 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 | 0 |
| Event Location | 0 |
| 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-2100B |
| Generic Name | CPBP SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2015-05-19 |
| Model Number | 4103202 |
| Lot Number | 047766 |
| Device Expiration Date | 2018-10-28 |
| Operator | OTHER |
| 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 | 2015-05-19 |