BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9310410 · Received November 12, 2019

    Report

    Report Number
    1710034-2019-01212
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 25, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814337
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED THIRTEEN 20 GAUGE INSYTE AUTOGUARD UNITS FROM LOTS 9213348, AND 9116581 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR BOTH LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE TO THE UNITS. NEXT, A FUNCTION RETRACTION TEST WAS PERFORMED AND ALL UNITS WERE OBSERVED TO RETRACT SUCCESSFULLY. NO ISSUES WERE FOUND WITH THE UNITS' RETRACTION. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE OBSERVED DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 381433, BATCH NO: 9213348. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLES ARE RELEASING AND SHOOTING ACROSS THE ROOM. ONE NEEDLE WENT THROUGH THE PANT LEG OF AN EMPLOYEE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE COME ACROSS AN ISSUE HERE WITH THE IV CATHETERS (20 GA 1.00 IN) REF 381433. THE NEEDLES ARE RELEASING AND SHOOTING ACROSS THE ROOM. WE HAD AN EVENT WHEN ONE WENT THROUGH THE PANT LEG OF AN EMPLOYEE. FORTUNATELY SHE WAS NOT HARMED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    MATERIAL NO: 381433, BATCH NO: 9213348. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLES ARE RELEASING AND SHOOTING ACROSS THE ROOM. ONE NEEDLE WENT THROUGH THE PANT LEG OF AN EMPLOYEE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE COME ACROSS AN ISSUE HERE WITH THE IV CATHETERS (20 GA 1.00 IN) REF 381433. THE NEEDLES ARE RELEASING AND SHOOTING ACROSS THE ROOM. WE HAD AN EVENT WHEN ONE WENT THROUGH THE PANT LEG OF AN EMPLOYEE. FORTUNATELY SHE WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103364 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9213348 30382903814337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other