BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8203544 · Received December 28, 2018

    Report

    Report Number
    1710034-2018-00941
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 10, 2018
    Report Date
    January 30, 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

    H.6. INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8122560; THE LOT NUMBER WAS BUILT ON AFA LINE 1 FROM 02MAY18 THRU 08MAY18. PACKAGED ON PACKAGING LINE 8 FROM02MAY18 THRU 08MAY18. 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 STATED IN THE PIR. RECEIVED 182 UNUSED IAG 20GA UNITS IN SEALED PACKAGES FROM THE CATALOG NUMBER 381834; LOT NUMBER 8122560. 50 UNITS WERE RECEIVED IN A DISPENSER AND 132 UNITS WERE RECEIVED IN A PLASTIC BAG. 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 DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNITS. INDETERMINATE - THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, PER THE PIR. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNITS. THE ACTUAL UNIT DESCRIBED IN THE INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS THE SAFETY MECHANISM HAS A DELAYED REACTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS THE SAFETY MECHANISM HAS A DELAYED REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044168 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8122560 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other