BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE 2 ML WITH 25X1¿

    MDR report key: 14122431 · Received April 15, 2022

    Report

    Report Number
    2243072-2022-00470
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 6, 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. 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0214098; MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025; DEVICE MANUFACTURE DATE: 01-AUG-2020. MEDICAL DEVICE LOT #: 0242834; MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025; DEVICE MANUFACTURE DATE: 29-AUG-2020. MEDICAL DEVICE LOT #: 1175953; MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026; DEVICE MANUFACTURE DATE: 24-JUN-2021. INVESTIGATION SUMMARY: THE PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF A DISCARDIT 2ML FROM LOT # 0214098, 0242834, 1175953 REGARDING ITEM # 301866 WITH THE REPORTED ISSUE OF BLISTER MULTIPLE DEFECTS. THERE ARE NO SAMPLES AND 33 PHOTOGRAPHS RECEIVED FROM THE CUSTOMER ALONG WITH THE REPORTED COMPLAINT OF MULTIPLE DEFECTS. THE INVESTIGATING TEAM HAS ALSO USED THE RETENTION SAMPLES FROM LOT # 0214098, 0242834, 1175953 REGARDING ITEM # 301866 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 AND NONE OF THE MULTIPLE DEFECTS WERE FOUND. BASED ON THE PHOTOGRAPHS, THE DEFECTS ARE CONFIRMED. ALL THE LOTS WERE MANUFACTURED BETWEEN 2020 AND 2021. THERE ARE MULTIPLE ACTIONS TAKEN FROM 2021 ONWARDS UNDER THE QUALITY IMPROVEMENT PROGRAM WHICH IS CURRENTLY ONGOING. BLISTER DAMAGE- FOR BLISTER DAMAGE CHAIN ISSUE WAS IDENTIFIED AND LEADING TO LAMINATE HOLDING THUS CAUSING CUTTING ISSUES. CHAIN REPLACED AND FREQUENCY SET TO REPLACE CHAIN AFTER EVERY THREE YEARS. BASED ON THE PHOTOGRAPH DEFECT IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGE 2 ML WITH 25X1¿ A THE PACKAGING WAS FOUND TO BE DAMAGED. THIS OCCURRED 343 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES HAVING BLISTER LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138442 BD DISCARDIT¿ II SYRINGE 2 ML WITH 25X1¿ PISTON SYRINGE FMF BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown