BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7089437 · Received December 6, 2017

    Report

    Report Number
    1710034-2017-00442
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825579
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - BD RECEIVED NINE IAG 16GA UNITS FROM LOT NUMBER 5121525. THE DEFECT OF PACKAGE SEAL INTEGRITY, AS STATED IN THE EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNIT. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH ARE: SEAL TRANSFER AND TOP WEB GLUE, MEASURED WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. THE DEFECT OF NEEDLE RETRACTION FAILURE COULD NOT BE CONFIRMED, NO PHYSICAL MECHANICAL EVIDENCE WAS FOUND TO TRIGGER THE FAILURE AND THE UNIT SUCCESSFULLY RETRACTED UPON ACTIVATION OF THE WHITE BUTTON. NO SIGNIFICANT ISSUES WERE FOUND DURING THE REVIEW OF THE DEVICE HISTORY RECORD. CONCLUSION - COMPLAINT CONFIRMED. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THE PACKAGE SEAL INTEGRITY ISSUE (SEE CAPA (B)(4)).

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND BEFORE USE WITH SEVERAL MALFUNCTIONS. THE GLUE APPEARED DISINTEGRATED ON THE PACKAGES EDGES AS ¿THE PEEL APART EDGES WERE CURLED BACK AND PACKAGES APPEARED TO BE SPONTANEOUSLY OPENING¿ THIS CREATING A STERILE BARRIER BREACH. A SAFETY FAILURE WAS FOUND AS ¿THE ACTIVATION OF THE MECHANICAL BUTTON DOES NOT APPEAR TO RETRACT THE STYLET INTO THE SAFETY BARREL WITHOUT RESISTANCE.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865170 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5121525 30382903825579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other