MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-08 for Q2 T-EXTENSION SET 95702 manufactured by Quest Medical, Inc..
[138570246]
The alleged incident occurred outside the us. This medwatch is being submitted because quest medical distributes a similar device in the us. The complaint sample will be evaluated and a follow-up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[138570247]
A report was received regarding an alleged issue encountered during use of the iv administration extension set. The report states that the iv tubing pulled apart which resulted in a patient not receiving infusions and bleeding from central line insertion site. Additional information received indicates that the alleged malfunction did not result in patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00010 |
| MDR Report Key | 8405790 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-08 |
| Date of Report | 2019-04-11 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-03-08 |
| 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 | 3 |
| Brand Name | Q2 T-EXTENSION SET |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2019-03-08 |
| Returned To Mfg | 2019-03-05 |
| Model Number | 95702 |
| Catalog Number | 95702 |
| Lot Number | 0567388C03 |
| Device Availability | R |
| 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 | 2019-03-08 |