BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 14501638 · Received May 25, 2022

    Report

    Report Number
    3006425876-2022-00489
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 5, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902157970
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE INTRODUCER NEEDLE AND LIDSTOCK FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE PRESENT ON THE NEEDLE CANNULA. VISUAL ANALYSIS REVEALED THAT THE NEEDLE HUB WAS BROKEN AND SEPARATED. A PORTION OF THE DISTAL END OF THE HUB WAS STILL ADHERED TO THE NEEDLE CANNULA. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION WAS SMOOTH. IT WAS ALSO CONFIRMED THAT THE HUB ON THE RETURNED SAMPLE IS THE NEW HUB DESIGN, WHICH MATCHES THE BILL OF MATERIALS. FUNCTIONAL INSPECTION WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE REPORT OF A SEPARATED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. BASED ON THE SAMPLE PROVIDED, DESIGN LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. A CAPA WAS OPENED TO FURTHER INVESTIGATION THIS ISSUE. 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 THE NEEDLE HUB BROKE AND SEPARATED DURING INSERTION. NO PATIENT HARM. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE HUB BROKE AND SEPARATED DURING INSERTION. NO PATIENT HARM. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392959 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN914770 71F21F0035 10801902157970

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown