BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8187321 · Received December 20, 2018

    Report

    Report Number
    1710034-2018-00973
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 20, 2018
    Report Date
    February 20, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AFA LINE 12 FROM 13JUL18 THROUGH 18JUL18. THERE WERE 3 INSTANCES WHERE THE CHALLENGE SAMPLES WERE NOT NOTED AS PASS OR FAIL (REJECT WEDGE CHALLENGE, PLUG DEPTH ATTRIBUTE CHALLENGE AND SPLAY LUBE CHALLENGE), OF WHICH NONE WERE RELATED TO THIS INCIDENT. THESE NON-RECORDED (PASS/FAIL) CHALLENGES ARE BEEN ADDRESSED BY THE QE. ALL OTHER CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. RECEIVED A TOTAL OF (B)(4) UNITS WITHIN SEALED PACKAGES ALONG WITH 3 EMPTY-OPEN PACKAGES FROM LOT NUMBER 8192723. ALL THE CONTENTS WITHIN THE SEALED PACKAGES WERE PRESENT. VISUAL EVALUATION: 4 OF THE (B)(4) UNITS RECEIVED REVEALED DAMAGE (STRESS MARKS, PARTIAL BENDING) ON THE SAFETY BARREL. UPON PRESSING THE ACTIVATION BUTTON THE NEEDLE ONLY PARTIALLY RETRACTED, THE DAMAGE FOUND ON THE BARRELS PREVENTED FULLY RETRACTION. ROOT CAUSE: MANUFACTURING: THE NEEDLE RETRACTION FAILURE DESCRIBED IN THE INCIDENT REPORT WAS POTENTIALLY CAUSED BY THE DAMAGE (CRACKS, STRESS MARKS) FOUND ON THE SAFETY BARREL WHICH WAS CAUSED BY MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 NEEDLE FAILED TO RETRACT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026709 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8192723 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other