MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-28 for Q2 EXTENSION SET, 17 INCH 95902 manufactured by Quest Medical, Inc..
[93601619]
The device was discarded by the customer and the lot number was not provided. A follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[93601620]
A customer reported an issue encountered with the q2 extension set. The report states that the patient notified the registered nurse that the bite infusion tubing filter was leaking. About 1 sheet size of paper spill on bed soaked into sheets - patient was not sitting in it. One drop of bite was found on the patient's arm. Infusion was immediately stopped and the pharmacy and attending were notified there were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00097 |
| MDR Report Key | 7064301 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-28 |
| Date of Report | 2018-01-09 |
| Date Mfgr Received | 2017-11-07 |
| Date Added to Maude | 2017-11-28 |
| 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 | 2017-11-28 |
| Model Number | 95902 |
| Lot Number | NOT PROVIDED |
| Operator | NURSE |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2017-11-28 |