BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS, BIOFLO, PASV

    MDR report key: 5276858 · Received December 3, 2015

    Report

    Report Number
    1317056-2015-00204
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    PMA / PMN Number
    K121089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECS. A REVIEW OF THE (B)(6) 2015 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE BIOFLO PASV PICC PRODUCT FAMILY AND THE FAILURE MODE "HUB BROKEN/CRACKED." NO ADVERSE TREND WAS IDENTIFIED. AS RECEIVED, AN INJECTION CAP/NEEDLESS CONNECTOR (NOT SUPPLIED BY ANGIODYNAMICS) WAS RETURNED, UNATTACHED, WITH THE CATHETER. THE FEMALE LUER LOCK COMPONENT OF THE PURPLE VALVE ON THE PICC WAS CONFIRMED TO BE CRACKED JUST ADJACENT TO THE MOLDED PARTING LINE. THE MOST LIKELY ROOT CAUSE FOR THE CRACK ALONG THE VALVE PARTING LINE IS AN OVER-TIGHTENED CONNECTION WITH A MATING MALE LUER (LIKELY THE NEEDLELESS CONNECTOR). (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTION IN THE (B)(6), AN INDWELLING PICC DEVICE HAD TO BE REMOVED DUE TO A CRACK IN THE VALVED HUB LUER. NO PT INJURY OR COMPLICATIONS WERE REPORTED. THE USED PICC HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794053 ANGIODYNAMICS, BIOFLO, PASV PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS NA 4834863

    Patients

    Seq Age Sex Outcome Treatment
    1