BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD

    MDR report key: 8748422 · Received July 1, 2019

    Report

    Report Number
    1710034-2019-00692
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD EXPERIENCED A NEEDLE THAT FAILED TO RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381434 BATCH NO.: 9021528. RETRACTION FAILURE NO ADVERSE EVENTS.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD EXPERIENCED A NEEDLE THAT FAILED TO RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381434, BATCH NO.: 9021528. VERBATIM: RETRACTION FAILURE. NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542620 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9021528 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other