BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 14353534 · Received May 11, 2022

    Report

    Report Number
    3006425876-2022-00460
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 14, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED MULTIPLE COMPONENTS FROM A CVC KIT AND A LIDSTOCK FOR ANALYSIS. THE INTRODUCER NEEDLE WILL BE ANALYZED AS PART OF THIS COMPLAINT INVESTIGATION. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS REVEALED THAT THE INTRODUCER NEEDLE HUB WAS BROKEN AND SEPARATED. CRACKS WERE ALSO OBSERVED ON THE HUB. THE MAJORITY OF THE HUB WAS STILL MOLDED TO THE PROXIMAL END OF THE NEEDLE CANNULA. THE NEEDLE LENGTH (PER MEASUREMENT A IN THE CANNULA PRODUCT DRAWING) MEASURED 2.756", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.732"-2.792". THE CANNULA OUTER DIAMETER MEASURED .0498" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495"-.0505" PER THE CANNULA PRODUCT DRAWING. THE CANNULA INNER DIAMETER AT THE DISTAL AND PROXIMAL ENDS MEASURED .041" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA PRODUCT DRAWING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF A BROKEN/SEPARATED NEEDLE HUB WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT A PORTION OF THE NEEDLE HUB WAS SEPARATED FROM THE ASSEMBLY. DESPITE THE DAMAGE, THE NEEDLE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. IT WAS DETERMINED THAT THE ROOT CAUSE FOR THIS ISSUE IS LIKELY DESIGN RELATED. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. THE MANUFACTURING DATE FOR THE NEEDLE HUB INVOLVED WITH THIS COMPLAINT OCCURRED PRIOR TO THE CAPA IMPLEMENTATION DATE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE PERFORMING THE PROCEDURE, THE DOCTOR FOUND THE NEEDLE WAS BROKEN. A NEW DEVICE WAS USED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE PERFORMING THE PROCEDURE, THE DOCTOR FOUND THE NEEDLE WAS BROKEN. A NEW DEVICE WAS USED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871190 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21D1727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown