BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 19278261 · Received May 9, 2024

    Report

    Report Number
    1911916-2024-00338
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR CORRECTION - DUPLICATE. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS IS A DUPLICATE OF COMPLAINT PR (B)(4). THIS MDR IS BE VOID.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL #:302830 BATCH#:4059791. IT WAS REPORTED BY CUSTOMER THAT THE 20 ML LUER-LOK TIP SYRINGE OPENED TO DRAW UP MEDICATIONS. SEAL WAS INTACT SO THE SYRINGE WAS "STERILE", BUT THERE WAS QUESTIONABLE RED/BROWN SUBSTANCE ON THE SYRINGE END THEREFORE CONTAMINATED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. EVENT DATE: 4-26-2024 EVENT DESCRIPTION: ¿20 ML LUER-LOK TIP SYRINGE OPENED TO DRAW UP MEDICATIONS. SEAL WAS INTACT SO THE SYRINGE WAS "STERILE", BUT THERE WAS QUESTIONABLE RED/BROWN SUBSTANCE ON THE SYRINGE END (THEREFORE CONTAMINATED).¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY. PRODUCT NAME: ITEM-1120080 - SYRINGE 20ML LUER LOC TIP PRODUCT REF: (B)(4) LOT NUMBER: 4059791 BD CUSTOMER ACCOUNT NUMBER: (B)(6). NO PHOTO OR SAMPLE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489338 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4059791 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown