BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5506101 · Received March 16, 2016

    Report

    Report Number
    1213809-2016-00013
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Date of Event
    March 4, 2016
    Report Date
    March 16, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 # 5243999. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS DOING HOME DIALYSIS AND IN THIS PROCESS A 10 ML BD LUER-LOK SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE NEEDLE WAS USED. THE PATIENT HAD FALLEN ASLEEP AND APPROXIMATELY AN HOUR AND A HALF LATER WOKE UP AND NOTICED THAT BLOOD HAD LEAKED FROM THE CONNECTION BETWEEN THE SYRINGE THAT HOLDS THE HEPARIN AND THE HEPARIN LINE FROM THE BLOOD LINE DUE TO AN UNSECURE CONNECTION. THERE WAS NOT A MASSIVE AMOUNT OF BLOOD LOSS, APPROXIMATELY 50ML. THERE WAS NO INJURY TO THE PATIENT AND SHE DID NOT RECEIVE ANY TREATMENT, HOWEVER THE PATIENT DID RECEIVE LAB WORK TO CHECK HER HGB LEVEL. THE PATIENT'S HGB LEVEL PRIOR TO THE INCIDENT WAS 11.4 AND AFTER THE INCIDENT IT WAS 10.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161084 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE SYRINGE AND NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 5243999

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention