MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-01-29 for RLV-2100 VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc.
[98545951]
The lot number of the device was not provided, a dhr review could therefore not be completed. A 24 months complaint history review was conducted on the part number and no similar complaint was identified. A non-conformance review was also conducted and no similar non-conformity as identified in the complaint was found. The root cause of this issue is unknown. The device malfunction was identified in a manufacturing facility in an ous country. This medwatch is being submitted because a similar device is marketed by quest medical in us.
Patient Sequence No: 1, Text Type: N, H10
[98545952]
A report received from a customer states that the device was found to be defective during production assembly process.
Patient Sequence No: 1, Text Type: D, B5
[132407561]
Visual inspection of the device showed poor welding as the root cause of the issue. A dhr review revealed that the weld setting parameters for this lot were within qualified settings. Parts are 100% leak tested as part of the manufacturing process for the device. The yield for the lot was found to be at 99. 9%. Based on the reject quantity, this issue is categorized as an isolated incident. Quest medical will continue to monitor complaint trends for this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00015 |
| MDR Report Key | 7224335 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-01-29 |
| Date of Report | 2018-03-12 |
| Date Mfgr Received | 2018-01-02 |
| Device Manufacturer Date | 2016-05-10 |
| Date Added to Maude | 2018-01-29 |
| 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 | TOSAN ONOSODE |
| 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 VACUUM RELIEF VALVE |
| Generic Name | CARDIOPULMONARY SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2018-01-29 |
| Returned To Mfg | 2018-01-11 |
| Model Number | 4103202 |
| Catalog Number | 4103202 |
| Lot Number | 051358 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-01-29 |