MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-23 for Q2 EXTENSION SET, 17 INCH 95902 manufactured by Quest Medical, Inc..
[90771741]
At the time of this report, no patient information was provided. The device was discarded by the customer and the lot number was not provided. A review of the device history record could therefore not be conducted. A review of the complaint and non-conformance records for this product code in the last 24 months was conducted and no similar issue was identified. The manufacturing process for this product line was also reviewed and no quality issues were identified. Quest medical has implemented several internal quality controls to ensure only conforming products are shipped out including but not limited to in-process inspection, final inspection and a dhr review prior to product release. A supplemental medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[90771742]
Report received states that chemo leaked from below filter where the tubing is bonded to the filter. The medication being infused was etoposide. There were no patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00080 |
| MDR Report Key | 6970841 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-19 |
| Date Mfgr Received | 2017-09-21 |
| Date Added to Maude | 2017-10-23 |
| 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 EXTENSION SET, 17 INCH |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2017-10-23 |
| Model Number | 95902 |
| Lot Number | NOT PROVIDED |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-10-23 |