BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET/J/60DROP/1CQ/SB/50CM/PB

    MDR report key: 8281844 · Received January 28, 2019

    Report

    Report Number
    2243072-2019-00123
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 7, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: WE CONFIRMED THE ACTUAL PRODUCT WE RECEIVED, BUT AS IT WAS OFFERED, A LIQUID LEAK WAS RECOGNIZED FROM THE CONNECTION OF THE BOTTLE NEEDLE AND THE TUBE. THE TUBE WAS FOUND TO BE BROKEN AT THE LEAK. THIS PRODUCT HAS BEEN SUBJECTED TO 100% APPEARANCE INSPECTION IMMEDIATELY BEFORE BEING PUT INTO INDIVIDUAL PACKAGING, AND SHIPMENT TESTS IN ALL PAST PRODUCTION LOTS (THE RELEVANT JIS TENSILE STRENGTH STANDARD: ABNORMAL WHEN APPLIED FOR 15 SECONDS OR MORE WITH A FORCE OF 15N OR MORE) AND, IN THE RELEVANT JIS AIR TIGHTNESS STANDARD: 50 KPA, NO AIR LEAK DUE TO PRESSURIZATION FOR 15 SECONDS. SINCE THE TUBE WAS BROKEN AT THE END OF THE BOTTLE NEEDLE, ETC., IT WAS ESTIMATED THAT THIS EVENT WAS BROKEN DUE TO THE LOAD IN THE BENDING DIRECTION BEING APPLIED TO THE RELEVANT PART DURING USE, AND THE LIQUID LEAKED. AS DESCRIBED IN THE PACKAGE INSERT, THERE IS A RISK OF DAMAGE OR CRACKING DEPENDING ON THE HANDLING, SO PLEASE BE CAREFUL WHEN HANDLING THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE CONNECTION OF THE IV SET/J/60DROP/1CQ/SB/50CM/PB EXTENSION TUBING AND SPIKE NEEDLE.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 LEAKAGE OCCURRED FROM THE CONNECTION OF THE IV SET/J/60DROP/1CQ/SB/50CM/PB EXTENSION TUBING AND SPIKE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73280 IV SET/J/60DROP/1CQ/SB/50CM/PB INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 1808041C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other