BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CRITICAL CARE PRESET SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7059208 · Received November 27, 2017

    Report

    Report Number
    9617032-2017-00175
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    April 7, 2016
    Report Date
    November 6, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT THAT SHOWS BLOOD LEAKAGE BEHIND THE PLUNGER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5051022. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® CRITICAL CARE PRESET SYRINGE WITH ATTACHED NEEDLE LEAKED BLOOD ON PAST THE PLUNGER ON THE SYRINGE DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTIONS REPORTED. NO MUCOUS MEMBRANE EXPOSURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840520 BD VACUTAINER® CRITICAL CARE PRESET SYRINGE WITH ATTACHED NEEDLE SYRINGE JKA BECTON, DICKINSON AND COMPANY (BD) 5051022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other