MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for Q2 IV EXTENSION SET 95906 manufactured by Quest Medical, Inc.
[93689079]
The device has been returned for investigation which is in progress. A follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[93689080]
A customer reported an issue encountered with the q2 extension set. The report states that blood leaked from the q2 port following removal of the pivo. The nurse attempted to flush the q2 to stop the blood. It stopped while flushing then continued leaking. After replacing the q2 the leaking stopped. There were no patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00094 |
| MDR Report Key | 7064309 |
| Date Received | 2017-11-28 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2017-11-01 |
| 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 | 0 |
| Brand Name | Q2 IV EXTENSION SET |
| Generic Name | IV EXTENSION SETS |
| Product Code | FPK |
| Date Received | 2017-11-28 |
| Returned To Mfg | 2017-11-15 |
| Model Number | 95906 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-11-28 |