BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 5702427 · Received June 6, 2016

    Report

    Report Number
    1213809-2016-00022
    Event Type
    Injury
    Date Received
    June 6, 2016
    Date of Event
    May 10, 2016
    Report Date
    June 20, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6001872. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE ON A DIALYSIS CATHETER, IT WAS NOTICED THAT THE TIP OF THE PLUNGER WAS MALFORMED WHICH CAUSED AIR TO ENTER THE DIALYSIS CATHETER. THE PATIENT WAS TRANSFERRED TO A HOSPITAL WHERE THE DIALYSIS CATHETER WAS EXCHANGED. THE PATIENT REMAINED INPATIENT AT THE HOSPITAL FOR SEVERAL DAYS AFTER THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355696 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE SYRINGE AND NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 6001872

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R