MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET; INTRAVASCULAR ADMINISTRATION EXTENSION SET

Model Number	95711
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION EXTENSION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6037669
• Report Number: 1649914-2016-00049
• Device Sequence Number: 19054975
• Product Code: FPK
• UDI-Device Identifier: 00634624957114
• UDI-Public: 00634624957114
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K800825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/01/2018
• Device Model Number: 95711
• Device Lot Number: 0489865Y03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 MO
• Patient Weight: 5