BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT ¿ II

    MDR report key: 12756124 · Received November 7, 2021

    Report

    Report Number
    2243072-2021-02673
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUATION?: YES D.9. RETURNED TO MANUFACTURER ON: 11/1/2021 H.6. INVESTIGATION: THE SAMPLE WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLE OF (1) DISCARDIT 2ML FROM LOT # 1030341 PRODUCT # 300844 WITH THE REPORTED ISSUE OF ¿LEAKAGE FROM THE SYRINGE TIP¿. THE DHR OF MATERIAL NUMBER 300844 AND LOT NUMBER 1030341 WAS CHECKED AND NO QUALITY NOTIFICATIONS WERE RECORDED ON THIS LOT. ONE SAMPLE AND NO PHOTOGRAPHS WERE RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECTS. THE INVESTIGATION TEAM ALSO USED RETENTION SAMPLES OF MATERIAL CODE 300844 AND LOT NUMBER 1030341 FOR INVESTIGATING THE REPORTED DEFECT. NONE OF THE TEN RETENTION SAMPLES SHOWED ANY LEAKAGE IN THEM. THE RECEIVED SAMPLE WAS TESTED FOR LEAKAGE, BY CHECKING IT UNDER WATER AND IT CONFIRMED THAT THERE WAS LEAKAGE FOUND IN THE ORIGINAL SAMPLE. THE DEFECT IS CONFIRMED. THE PROBABLE ROOT CAUSE COULD BE THE HIGH STAMPING PRESSURE WHICH CAN CAUSE CRACK ON THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED BD DISCARDIT ¿ II HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE FROM THE SYRINGE TIP."

    Description of Event or Problem · 0

    IT WAS REPORTED BD DISCARDIT ¿ II HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE FROM THE SYRINGE TIP"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661962 BD DISCARDIT ¿ II PISTON SYRINGE FMF BECTON DICKINSON 1030341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown