BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20813828 · Received November 30, 2024

    Report

    Report Number
    1213809-2024-00900
    Event Type
    Malfunction
    Date Received
    November 30, 2024
    Date of Event
    October 26, 2024
    Report Date
    June 7, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BARREL / FLANGE DAMAGED. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    (B)(4) CORRECTION: FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR, AND THE COMPLAINT WILL BE CANCELLED. THE ASSOCIATED MDR WILL BE VOID.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. 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 WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL # 309657. BATCH # UNKNOWN. IT WAS REPORTED THAT THE BD LUER-LOK BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. "CALLER REPORTED CALLER WAS PULLING SYRINGE, AND AS HE WAS TAKING OUT THE EXCESS AIR FROM CARTRIDGE THE SYRINGE SHATTERED, CAUSING CALLER TO LOSE HIS INSULIN. WITH HOW MANY SYRINGES/NEEDLES DID THE CALLER EXPERIENCE THE ISSUE? ¿ ONE. WAS THE SYRINGE/NEEDLE REUSED? - NO. PRODUCT WITH ISSUE - BD 3ML SYRINGE, PN 309657. IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ YES. CTS INFORMED CALLER BD MIGHT FOLLOW UP REGARDING RETURN OF SYRINGE/NEEDLE. CALLER ACKNOWLEDGED. PRODUCT LOT # - 230506. DID ISSUE CAUSE ANY INJURY? - NO. HOW DID THE CUSTOMER RESOLVE THE ISSUE? ¿ CHANGED SYRINGE ONLY AND SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. RESOLUTION ¿ NO FURTHER XXX FOLLOW UP IS REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470034 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male