BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8433052 · Received March 19, 2019

    Report

    Report Number
    1710034-2019-00300
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 28, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS AND SAMPLE PROVIDED BY YOUR FACILITY. BD RECEIVED ONE 22GA INSTYE AUTOGUARD BC UNIT WITHIN AN OPEN PACKAGE FROM LOT NUMBER 8142645. ONE PHOTOGRAPH WAS ALSO SUBMITTED FOR REVIEW WHICH DISPLAYED A PACKAGE LABEL AND A 22GA UNIT WITH A RED CIRCLE AROUND THE FOREIGN MATTER PRESENT INSIDE THE NEEDLE COVER. THROUGH THE VISUAL/MICROSCOPIC EXAMINATION IT WAS IMMEDIATELY OBSERVED TO HAVE BLACK PARTICLE/SPECKS THROUGH THE NEEDLE COVER AND ON THE SHAFT OF THE CATHETER TUBING. THE PHOTOGRAPH DISPLAYED SIMILAR FINDINGS TO THAT OF THE RETURNED UNIT. THE DEFECT OF FOREIGN MATTER, AS STATED IN THE REPORTED ISSUE WAS CONFIRMED. THE BLACK SPECKS OF FOREIGN MATTER WERE FOUND TO BE BURNT PARTICULATE RESIN THAT WAS INTRODUCED DURING THE MOLDING PROCESS. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE MOLDING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "COMPLAINT FROM HONG KONG BAPTIST HOSPITAL. THE USER COMPLAINTED THAT FOREIGN MATERIALS WAS FOUND IN THE PACKING WHEN UNPACKING."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "COMPLAINT FROM (B)(6). THE USER COMPLAINED THAT FOREIGN MATERIALS WAS FOUND IN THE PACKING WHEN UNPACKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227903 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8142645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other