BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS / BIOFLO

    MDR report key: 6571958 · Received May 17, 2017

    Report

    Report Number
    1317056-2017-00037
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    March 15, 2017
    Report Date
    November 2, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    UDI-DI
    H965750385
    PMA / PMN Number
    K140266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT HAS BEEN INDICATED THAT THE DEVICE FROM THE REPORTED EVENT WILL BE RETURNED FOR EVALUATION, IT HAS NOT YET ARRIVED AT ANGIODYNAMICS. UPON RECEIPT OF THE RETURNED SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4)). DEVICE NOT YET RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE INDICATED PACKAGING AND PICC ASSEMBLY COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SEPTEMBER 2017 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE BIOFLO PICC PRODUCT FAMILY AND THE FAILURE MODE "CATHETER/GUIDEWIRE FIT ISSUE - INTERVENTION REQUIRED. " NO ADVERSE TREND WAS INDICATED. AS NO USED SAMPLES WERE RETURNED TO ANGIODYNAMICS DESPITE MULTIPLE GOOD FAITH EFFORTS, THE COMPLAINT IS UNABLE TO BE CONFIRMED, NOR CAN A ROOT CAUSE BE DETERMINED. THE GUIDEWIRE IS PURCHASED BY ANGIODYNAMICS FROM HERAEUS MEDICAL. THEY WERE NOTIFIED OF THE REPORT VIA A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). ALTHOUGH THEY WERE UNABLE TO DETERMINE IF THERE WAS A GUIDEWIRE FAILURE (NO SAMPLE WAS RETURNED), THEY REVIEWED THE DHR FOR THE GUIDEWIRE USED IN THE REPORTED PACKAGED DEVICE LOT. NO OBSERVATIONS WERE MADE DURING THE REVIEW OF THE RECORDS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. ANGIODYNAMICS MANUFACTURING PROCESS CONTROLS FOR THE BIOFLO PICC DEVICE INCLUDE 100% IN-PROCESS VISUAL INSPECTION FOR MOLDING DEFECTS, A GUIDEWIRE INSERTION TEST TO VERIFY LUMEN PATENCY AND ALL CATHETERS BEING SPRINT TESTED AFTER THE GUIDEWIRE VERIFICATION TO ENSURE THAT THE CATHETERS DO NOT LEAK. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED, ON USER/VOLUNTARY MEDWATCH MW5068658, "WHILE INSERTING THE PICC LINE, THE CATHETER BECAME CRIMPED WHEN ATTEMPTING TO REMOVE STYLET. SURGEON HAD TO COME AND REMOVE CATHETER SURGICALLY." IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352919 ANGIODYNAMICS / BIOFLO PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 5154952 H965750385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention