MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for Q2 CHECKMATE EXTENSION SET 9545 manufactured by Quest Medical, Inc..
[92603676]
There were no patient complications associated with the alleged issue. The device was not returned for evaluation. A similar product which undergoes the same manufacturing process as the product complained about was evaluated and no leakage was observed. Dhr review conducted did not identify any manufacturing issues. The root cause of the alleged defect is unknown.
Patient Sequence No: 1, Text Type: N, H10
[92603677]
The hospital reported an issue encountered with the intravenous administration extension set during use. The report stated that when they tighten the spin connector on the device it keeps turning and "strips" causing product to leak; it has happened on multiple occasions. There were no patient complications reported as a result of the alleged event. The device was not returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00077 |
| MDR Report Key | 7011798 |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-11-08 |
| 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 | 0 |
| Brand Name | Q2 CHECKMATE EXTENSION SET |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2017-11-08 |
| Model Number | 9545 |
| Catalog Number | 9545 |
| Lot Number | 0502535D06 |
| Operator | PHYSICIAN |
| 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 | 2017-11-08 |