BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT EXTENSION SET, 10 INCH

    MDR report key: 5703466 · Received June 7, 2016

    Report

    Report Number
    1649914-2016-00025
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 8, 2016
    Report Date
    June 28, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    UDI-DI
    00634624952003
    PMA / PMN Number
    K151079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION FOUND THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. DESTRUCTIVE TESTING OF THE CAP WELDS FOUND SUFFICIENT WELDS WERE PRESENT AT ALL CAP WELD LOCATIONS. THE EXACT LOT NUMBER OF THE AFFECTED DEVICE WAS NOT PROVIDED; HOWEVER, DISTRIBUTION RECORDS WERE AVAILABLE TO IDENTIFY 5 POTENTIAL LOTS OF PRODUCT. REVIEW OF THE APPLICABLE DEVICE HISTORY RECORDS FOUND NO ANOMALIES AND NO MANUFACTURING ISSUES RELATED TO THE REPORTED COMPLAINT. IT IS POSSIBLE THE REPORTED COMPLAINT WAS DUE TO MISHANDLING OR DAMAGE TO THE DEVICE WHILE IN USE BY THE END USER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT/INITIAL REPORTER DID NOT KNOW THE LOT NUMBER OF THE AFFECTED PRODUCT. THEY REPORTED THAT THEY HAD 5 LOTS OF THE RELEVANT PRODUCT CODE ON HAND, WHICH ARE: 050323, 050069, 050433, 050676, 050776 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.

    Description of Event or Problem · 1

    THE HOSPITAL RISK MANAGER REPORTED AN ISSUE ENCOUNTERED WITH THE DEVICE DURING USE. THE REPORT STATED THAT THE PATIENT HAD UNDERGONE A CORONARY ARTERY BYPASS AND WAS IN THE SURGICAL INTENSIVE CARE UNIT (SICU). TWO DAYS AFTER THE PROCEDURE THE NURSE CARING FOR THE PATIENT NOTICED THAT ONE PORT OF THE ADMINISTRATION MANIFOLD HAD COME OFF AND THAT MEDICATION WAS DRIPPING ONTO THE FLOOR. THE REPORT LISTED THE MEDICATION AS AMIODARONE. THE REPORT STATED THE NURSE CORRECTED THE PROBLEM. THERE WERE NO PATIENT OR PROVIDER COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359785 Q2 MULTIPORT EXTENSION SET, 10 INCH INTRAVASCULAR ADMINSTRATION AND EXTENSION SETS FPA QUEST MEDICAL, INC. 9520 00634624952003

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention