BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT

    MDR report key: 12656585 · Received October 19, 2021

    Report

    Report Number
    3006425876-2021-00977
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 28, 2021
    Report Date
    September 28, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE INTRODUCER NEEDLE FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED INSIDE THE NEEDLE HUB. VISUAL ANALYSIS REVEALED THAT THE INTRODUCER NEEDLE HUB WAS BROKEN AND SEPARATED. A PORTION OF THE NEEDLE HUB WAS STILL MOLDED TO THE PROXIMAL END OF THE NEEDLE CANNULA. THE NEEDLE LENGTH (PER MEASUREMENT A IN THE INTRODUCER NEEDLE GRAPHIC) MEASURED 68MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 67.49MM-69.27MM. THE CANNULA OUTER DIAMETER MEASURED .0498" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495"-.0505" PER THE CANNULA GRAPHIC. THE CANNULA INNER DIAMETER AT THE DISTAL AND PROXIMAL ENDS MEASURED .041" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE HUB OF THE NEEDLE WAS TESTED WITH THE MALE LUER GAGE AND WAS WITHIN THE SPECIFIED RANGE. THIS INDICATES THAT THE HUB CONFORMS TO ISO 594-1:1986. THE CUSTOMER WAS NOT ABLE TO PROVIDE A FINISHED GOOD MATERIAL#/LOT#; HOWEVER A POTENTIAL MATERIAL#/LOT# WAS OBTAINED BASED ON A SALES HISTORY REVIEW FOR THIS CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON THIS POTENTIAL MATERIAL#/LOT# AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORTED COMPLAINT OF A CRACKED AND SEPARATED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION ON THE RETURNED SAMPLE. THE RETURNED INTRODUCER NEEDLE HUB WAS CRACKED. A PORTION OF THE HUB WAS STILL MOLDED TO THE PROXIMAL END OF THE NEEDLE CANNULA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON THIS POTENTIAL MATERIAL#/LOT# AND NO RELEVANT FINDINGS WERE IDENTIFIED. FURTHER INVESTIGATION OF THIS ISSUE IS BEING CONDUCTED UNDER A CAPA. THE CAPA FAILURE INVESTIGATION INDICATES THAT THE PROBABLE CAUSE IS DESIGN RELATED. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE NEEDLE HUB BROKE AND SEPARATED IN USE". NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION REPORTED TO BE "WELL".

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE NEEDLE HUB BROKE AND SEPARATED IN USE". NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION REPORTED TO BE "WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558695 ARROW CVC KIT CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown