MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 MULTIPORT EXTENSION SET - 10 INCH; INTRAVASCULAR ADMINISTRATION SET

Model Number	9520
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2016
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 product distributor reported an issue encountered by the clinician while using the intravascular administration extension set.The report details stated that "air was entering thru distal end of manifold." follow-up with the complainant found that there were no patient complications and another device was used instead.The device was returned to the manufacturer for evaluation.``.
Additional Manufacturer Narrative
The alleged complaint condition could not be duplicated in the sample device nor in devices from the same lot tested.It is possible that the clinician did not prime the side ports first then the main central port.

• Brand Name: Q2 MULTIPORT EXTENSION SET - 10 INCH
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6169977
• Report Number: 1649914-2016-00067
• Device Sequence Number: 13642290
• Product Code: FPA
• UDI-Device Identifier: 00634624952003
• UDI-Public: 00634624952003
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2017

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: Nurse
• Device Expiration Date: 08/11/2019
• Device Model Number: 9520
• Device Lot Number: 0518216G06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/11/2017
• 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