BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDITII 2 ML WITH 23 X1¿

    MDR report key: 14137251 · Received April 18, 2022

    Report

    Report Number
    2243072-2022-00491
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 1, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿ASPIRATION DIFFICULTY¿ WITH LOT NUMBER 1061113 REGARDING ITEM # 300846, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THERE ARE NO SAMPLES AND NO PHOTOGRAPHS FROM THE CUSTOMER ALONG WITH THE REPORTED COMPLAINT OF ASPIRATION DIFFICULTY. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF LOT NUMBER 1061113 REGARDING ITEM # 300846 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS TESTED THE SAMPLES AND NO ASPIRATION DIFFICULTY WAS FOUND. THE DEFECT IS NOT CONFIRMED. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE. 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 THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. THERE ARE NO SAMPLE AND NO PHOTOGRAPH FROM THE CUSTOMER ALONG WITH THE REPORTED COMPLAINT OF ASPIRATION DIFFICULTY. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MAT. NO. 300846 AND LOT NO. 1061113 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON 10 RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS TESTED THE SAMPLES FOR ASPIRATION DIFFICULTY AND NO ASPIRATION DIFFICULTY WAS FOUND IN THE 10 RETENTION SAMPLES. THE DEFECT IS NOT CONFIRMED. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT II 2 ML WITH 23 X1¿ LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE DILUTION OF COMIRNATY VACCINE, WHEN REMOVING 1.8 ML OF AIR FROM THE VACCINE VIAL TO EQUALIZE THE PRESSURE IN THE VACCINE VIAL, SIGNIFICANT AMOUNT OF DILUTED VACCINE WENT BACK INTO THE BARREL BEHIND THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818427 BD DISCARDITII 2 ML WITH 23 X1¿ PISTON SYRINGE FMF BECTON DICKINSON 1061113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown