MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for Q2 IV EXTENSION SET 95906 manufactured by Quest Medical, Inc.
[142538270]
The complaint sample was not returned for investigation and no lot number was provided. A dhr review could not be conducted without the lot number. A similar product was pulled from quest's inventory and the samples were tested. The reported complaint condition of media shooting outside the tubing could not duplicated. The root cause of the reported complaint is unknown. A possible root cause may be improper clamping of the tubing by the end user. Quest will continue to monitor trends for the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
[142538271]
The report received states that the clamps on the extension sets do not hold tightly and causes contrast dye to shoot out side tubing. Multiple patients have had to receive double doses of contrast media to complete studies and other means of clamping the tubing have had to be used to prevent the issue from happening. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00022 |
| MDR Report Key | 8529088 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-04-18 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-04-18 |
| 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 | 2019-04-18 |
| Model Number | 95906 |
| Device Availability | N |
| 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 | 2019-04-18 |