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.
[93689035]
At the time of this report, the device has not been returned for investigation. A dhr/process review will be conducted and a follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[93689036]
A customer report received states that the white clamps on the extension sets have been very loose and have been falling off. The report also states that the staff have had to clamp the tubing so there is no chance for communication from any saline or solution left in the tubing being drawn back and in cases with iv fluid running the staff have had to disconnect the fluids. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00098 |
| MDR Report Key | 7064316 |
| Date Received | 2017-11-28 |
| Date of Report | 2018-01-18 |
| Date Mfgr Received | 2017-11-09 |
| 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 |
| Model Number | 95906 |
| Lot Number | 054629 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-11-28 |