BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8453411 · Received March 26, 2019

    Report

    Report Number
    1710034-2019-00331
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 8, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION:REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT. RECEIVED FOUR UNUSED IAG 20GA UNITS IN SEALED PACKAGES FROM THE CATALOG NUMBER 381834; LOT NUMBER 8173559. VISUAL/MICROSCOPIC EVALUATION: OBSERVED THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS (SPRING, N NEEDLE HUB, GRIPS) OR EVIDENCE OF ADHESIVE ON THE BUTTON OR HUB. FUNCTIONAL TEST (NEEDLE RETRACTION) WAS PERFORMED: PERFORMED THE HUB TWIST TEST THEN DEPRESSED THE BUTTONS. THE RETRACTIONS WERE SUCCESSFUL, NO DELAYED REACTION WAS OBSERVED. THE DEFECT NEEDLE RETRACTION FAILURE WAS NOT IDENTIFIED, REPLICATED OR CONFIRMED WITH THE RETURNED UNITS. THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE ACTUAL UNIT DESCRIBED IN THE INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A RETRACTION ISSUE. THIS OCCURRED ON 4 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "THE SAFETY MECHANISM DELAY RETRACTED AND BLOOD SPLATTER, CAUSE BLOOD EXPOSURE TO PATIENT AND NURSE."

    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¿ SHIELDED IV CATHETER HAD A RETRACTION ISSUE. THIS OCCURRED ON 4 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "THE SAFETY MECHANISM DELAY RETRACTED AND BLOOD SPLATTER, CAUSE BLOOD EXPOSURE TO PATIENT AND NURSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247635 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8173559 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other