BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11382351 · Received February 25, 2021

    Report

    Report Number
    1213809-2021-00107
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 19, 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: G.5. PMA / 510(K)#: K980987 (B)(4). G.5. PMA / 510(K)#: K151766 (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WAS CRACKED AND SPRAYED OUT INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED THE SYRINGE CRACKED. AND SPRAYED INSULIN OUT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276806 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 32 YR