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

Model Number 9520

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2016

Event Type  malfunction  

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 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.``.

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
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 6169977
• MDR Text Key: 62678608
• Report Number: 1649914-2016-00067
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00634624952003
• UDI-Public: 00634624952003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention