MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-01-17 for VRV-IIC VACUUM RELIEF VALVE 4004103 manufactured by Quest Medical, Inc.
[133532710]
The alleged incident occurred outside of the us. This medwatch is being submitted because quest distributes a similar device in the us. The complaint sample was evaluated and the reported complaint condition was confirmed. A hole was seen on the pouch. The dhr was reviewed and no anomalies were seen. A 24 months complaint history review was conducted and no similar complaints have been received. The root cause of the reported complaint condition is unknown and this incident is considered isolated. Quest will continue to monitor complaints for trends.
Patient Sequence No: 1, Text Type: N, H10
[133532711]
The report received from the customer states that during incoming inspection, a hole was seen in the product pouch. The device was not used on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00002 |
| MDR Report Key | 8258069 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2019-01-17 |
| 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 | 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 | VRV-IIC VACUUM RELIEF VALVE |
| Generic Name | CPBP VACUUM RELIEF VALVE |
| Product Code | DWD |
| Date Received | 2019-01-17 |
| Returned To Mfg | 2019-01-03 |
| Model Number | 4004103 |
| Catalog Number | 4004103 |
| Lot Number | 0559248E14 |
| 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 | 2019-01-17 |