BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL W/NDL 25X5/8 RB

    MDR report key: 21211770 · Received January 22, 2025

    Report

    Report Number
    1213809-2025-00019
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 2, 2024
    Report Date
    February 7, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095705
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. THE SOLUTION WAS EXPELLED WITH NO ISSUED OBSERVED. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER: 1161233. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL # 309570 BATCH # 1161233 IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X5/8 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE COMES OFF OF SYRINGE ITEM(S): 309570 LOT(S): 1161233 DATE INCIDENT OCCURRED: ON GOING WAS THE PATIENT IMPACTED? YES, NEEDLE COMES OFF OF SYRINGE IF YES, DESCRIBE: 3 BOTTLES OF B12 WASTED IS A SAMPLE AVAILABLE? YES, CUSTOMER REQUEST? NEEDING REIMBURSEMENT FOR SYRINGES AND B12 CUSTOMER RESPONSE ON (B)(6) 2025. THAT¿S WHAT YOU CALL REALLY BAD MULTI-TASKING. SORRY. YES, I WAS WAITING FOR YOU TO CONTACT ME ABOUT THE BAD SYRINGES AND THE LOSS OF THREE BOTTLE SO MY B12 SERUM, WHICH IS COSTLY. THE BAD SYRINGES OCCURRED ON THESE DATES: (B)(6) 2024, (B)(6) 2024 AND (B)(6) 2025. I DID NOT GET A SHIPPING LABEL AND I¿M NOT SURE WHAT YOU WANT ME TO RETURN. I DISCARDED TWO OF THE THREE BAD SYRINGES. I HAVE THE OPEN AND NOW USELESS B12 BOTTLES AND TWO OF THE PHARMACY BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622113 BD SYRINGE 3ML LL W/NDL 25X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1161233 30382903095705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown