BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II 2 ML SYRINGE WITH 25G X 1" NEEDLE

    MDR report key: 15199453 · Received August 10, 2022

    Report

    Report Number
    2243072-2022-01301
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 13, 2022
    Report Date
    July 18, 2022
    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 AN OEM MANUFACTURING SITE. (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1210421, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026, DEVICE MANUFACTURE DATE: 22-JUL-2021. MEDICAL DEVICE LOT #: 1203828, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026, DEVICE MANUFACTURE DATE: 29-JUL-2021, THERE ARE NO SAMPLES AND 18 PHOTOGRAPHS ALONG WITH THE REPORTED COMPLAINT OF MULTIPLE DEFECTS. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL NUMBER 301866 AND LOT NUMBER 1210421, 1203828 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR MULTIPLE DEFECTS AND NO MULTIPLE DEFECTS WAS FOUND IN THE TEN RETENTION SAMPLES. THE DEFECTS ARE CONFIRMED. THE FOLLOWING ACTIONS ARE WORK IN PROGRESS FOREIGN MATTER/HAIR - MEECH TO BE INSTALLED ON MACHINE TO REMOVE LOOSE FOREIGN MATTER FROM BLISTERS. TARGET DATE- 15/DEC/2022. ALL THE ACTIONS ABOVE WILL BE MONITORED FOR EFFECTIVENESS CHECK FOR THE PERIOD OF 6 MONTHS AND REVIEWED BY THE OQC TEAM IN THE WEEKLY OQC MEETING. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II 2 ML SYRINGE WITH 25G X 1" NEEDLE FOREIGN PARTICULATES WERE FOUND IN THE FLUID PATHWAY. THIS OCCURRED 39,762 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES HAVING FOREIGN PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429090 BD DISCARDIT¿ II 2 ML SYRINGE WITH 25G X 1" NEEDLE PISTON SYRINGE FMF BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown