BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 11381960 · Received February 25, 2021

    Report

    Report Number
    1213809-2021-00103
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 12, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#:(B)(4). PMA / 510(K)#: (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ DISPOSABLE SYRINGES WITH THE BD LUER-LOK¿ TIP LEAKED INSULIN DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED THAT INSULIN LEAKED OUT BETWEEN TOP OF SYRINGE AND NEEDLE BEFORE FILLING CARTRIDGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278579 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR