BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDITII 2ML WITH 24X1

    MDR report key: 12476632 · Received September 15, 2021

    Report

    Report Number
    2243072-2021-02322
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 19, 2021
    Report Date
    September 2, 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

    Narratives

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: 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. INVESTIGATION SUMMARY: A PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF DISCARDITII 2ML WITH 24*1 ((B)(4)) LOT# 1030341, REGARDING ITEM # 300844 WITH THE REPORTED ISSUE OF ¿THERE IS 15-20% DRUG LEAKAGE FROM THE SYRINGE TIP DURING ANESTHESIA WHEN THE SYRINGE IS INSERTED INTO QUINCKE NEEDLE¿. THE DHR OF MATERIAL NUMBER 300844 AND LOT NUMBER 1030341 WAS CHECKED AND NO QUALITY NOTIFICATIONS WERE RECORDED ON THIS LOT. NO SAMPLES AND ONE PHOTOGRAPH 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. A SIMULATION WAS DONE USING THE RETENTION SAMPLES AND QUINCKE NEEDLE (NEEDLES HAVE A LUER LOCK CONNECTION) FOUND THAT THE SYRINGE WAS NOT COMPATIBLE WITH THE LUER LOCK. AS ONE PHOTOGRAPH AND NO ORIGINAL SAMPLES AVAILABLE FOR INVESTIGATION OF THE SYRINGES LEAKING AS REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3000 DISCARDITII 2ML WITH 24X1 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS 15-20% DRUG LEAKAGE FROM THE SYRINGE TIP DURING ANESTHESIA WHEN THE SYRINGE IS INSERTED INTO QUINCKE NEEDLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374072 DISCARDITII 2ML WITH 24X1 PISTON SYRINGE FMF BECTON DICKINSON 1030341

    Patients

    Seq Age Sex Outcome Treatment
    1