BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER LOK

    MDR report key: 5684 · Received April 5, 1993

    Report

    Report Number
    5684
    Event Type
    Malfunction
    Date Received
    April 5, 1993
    Date of Event
    March 10, 1993
    Report Date
    March 15, 1993
    Manufacturer
    B-D
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BARRELL OF SYRINGE CRACKS AS FLUID IS PURGED UNDER DIRECT HAND PRESSURE TO PLUNGER.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUER LOK FMF B-D 2K604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other