BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9185845 · Received October 14, 2019

    Report

    Report Number
    1710034-2019-01102
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 24, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED FIFTY 24 GAUGE INSYTE AUTOGUARD UNITS AND ONE EMPTY PACKAGE FROM LOTS 9128619 AND 9140539 FOR EVALUATION. 47 UNITS AND THE EMPTY PACKAGE WERE RECEIVED FOR LOT 9140539 AND 3 UNITS WERE FROM LOT 9128619. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED 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, THE NEEDLE COVERS WERE REMOVED AND THE CATHETERS REMAINED ON THE NEEDLE ASSEMBLIES. THE ADAPTERS WERE PROPERLY ASSEMBLED AND NO MIS-ORIENTATION WAS OBSERVED. THE NEEDLE HUBS WERE INSPECTED AND FOUND TO HAVE ADEQUATE ADHESIVE. FINALLY, THE NEEDLES WERE PULLED TO SEE IF MOVEMENT OCCURRED AND NO MOVEMENT WAS FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DETACHED AND STUCK THE NURSE. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412, BATCH NO.: 9140539. IT WAS REPORTED THAT THE NEEDLE CAME OUT OF THE CATHETER RESULTING IN A NEEDLE STICK TO THE NURSE. PER EMAIL: I DON'T EXPLICITLY SEE THAT THE LOT NUMBER IS IDENTIFIED IN THE REPORT. IF ANY PERSONS THAT WERE INVOLVED WITH THIS REPORT CAN PASS THAT ALONG, IT WOULD BE BENEFICIAL IN ESCALATING WITH BD. ALSO, IF ANY OF THE PRODUCTS WERE SAVED, THIS WOULD ASSIST IN THE ANALYSIS. ISSUE: WHEN USING AN ANGIOCATHER FOR IV PLACEMENT, THE NEEDLE FELL OUT OF THE CATHETER. THERE WERE THREE INCIDENTS IN WHICH THIS HAPPENED WITH ONE FALLING AND STICKING THE RN. DEFECT TRACKER WILL BE UPDATED AND COMPLETED WHEN MORE INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    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 NEEDLE DETACHED AND STUCK THE NURSE. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 9140539. IT WAS REPORTED THAT THE NEEDLE CAME OUT OF THE CATHETER RESULTING IN A NEEDLE STICK TO THE NURSE. PER EMAIL: I DON'T EXPLICITLY SEE THAT THE LOT NUMBER IS IDENTIFIED IN THE REPORT. IF ANY PERSONS THAT WERE INVOLVED WITH THIS REPORT CAN PASS THAT ALONG, IT WOULD BE BENEFICIAL IN ESCALATING WITH BD. ALSO, IF ANY OF THE PRODUCTS WERE SAVED, THIS WOULD ASSIST IN THE ANALYSIS. ISSUE: WHEN USING AN ANGIOCATHER FOR IV PLACEMENT, THE NEEDLE FELL OUT OF THE CATHETER. THERE WERE THREE INCIDENTS IN WHICH THIS HAPPENED WITH ONE FALLING AND STICKING THE RN. DEFECT TRACKER WILL BE UPDATED AND COMPLETED WHEN MORE INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977861 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9140539 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other