MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET 95711 manufactured by Quest Medical, Inc..
[57868103]
Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[57868104]
The distributor reported an issue encountered by one of their customers when using the iv administration extension set. The report stated that a 20cc luer lock syringe full of blood was attached to one of the device ports, and upon injection into the port blood squirted out of another port. The report stated the device was discarded and another manifold was used. The patient was 5 months old and the iv line was attached to an internal jugular central line. The complainant stated there was no harm caused to the patient but that the issue had occurrec in three different procedures. The complainant chose to return seven of the unused device to the distributor for analysis by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[58947687]
The complainant returned one device sample out of the package and six other devices (same lot) still sealed in their packages. The one device sample appeared to have not been used. Visual examination of the device found no anomalies. All seven samples were primed wtih water using a 20 cc syringe, to similate the conditions stated by the user. None of the samples leaked or squirted water from the port per the complaint. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2016-00049 |
| MDR Report Key | 6037669 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2015-05-04 |
| Date Added to Maude | 2016-10-18 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| 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 8.5 INCH DOUBLE T-SITE IV EXTENSION SET |
| Generic Name | INTRAVASCULAR ADMINISTRATION EXTENSION SET |
| Product Code | FPK |
| Date Received | 2016-10-18 |
| Returned To Mfg | 2016-09-22 |
| Model Number | 95711 |
| Lot Number | 0489865Y03 |
| Device Expiration Date | 2018-05-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2016-10-18 |