MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-27 for Q2 CHECKMATE EXTENSION SET 9545 manufactured by Quest Medical, Inc..
[137861181]
The device was not returned for evaluation. A dhr review could not be completed as the lot number was not provided. The root cause of the reported complaint condition is unknown. Quest will continue to monitor complaint trends.
Patient Sequence No: 1, Text Type: N, H10
[137861182]
A report was received regarding an alleged issue encountered during use of the intravenous administration extension set. The report states that the manifold leaked during surgery resulting in a delay in procedure. No picture of the product is available and the device is not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00009 |
| MDR Report Key | 8376214 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-02-27 |
| 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 | Q2 CHECKMATE EXTENSION SET |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2019-02-27 |
| Model Number | 9545 |
| Catalog Number | 9545 |
| 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 | 2019-02-27 |