BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML ARTERIAL BLOOD SAMPLE 70 LU+200/CA

    MDR report key: 10788286 · Received November 4, 2020

    Report

    Report Number
    3002637618-2020-00062
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 12, 2020
    Report Date
    March 9, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    IQG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED BY SMITHS MEDICAL: A TOTAL OF 702 UNOPENED DEVICES WERE RECEIVED FOR ANALYSIS. NO ISSUES WERE FOUND DURING VISUAL OR FUNCTIONAL TESTING OF THESE DEVICES. EXAMINATION OF THE SUBMITTED PHOTOGRAPHS, HOWEVER, CONFIRMED THE PRESENCE OF DAMAGED AND MISSING LUERS AS REPORTED. THIS CONFIRMED THE REPORTED COMPLAINTS. REVIEW OF BATCH HISTORY RECORDS FOR LOT #4010060 INDICATED THE PRODUCT MET ESTABLISHED ACCEPTANCE REQUIREMENTS. MANUFACTURING EQUIPMENT WAS ALSO REVIEWED DURING CURRENT PRODUCTION RUNS AND CONFIRMED THAT THE ASSEMBLY MACHINE WAS WORKING PROPERLY, AND NO DAMAGED PARTS WERE FOUND. A QUALITY ALERT WAS POSTED FOR MANUFACTURING PERSONNEL TO HEIGHTEN AWARENESS OF THIS ISSUE. COMPLAINT DATA WILL CONTINUE TO BE MONITORED FOR NEW INFORMATION, WITH ACTIONS TAKEN ACCORDINGLY. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE STAFF MEMBER STATED SHE HAD A SHOWER, AND WASHED HER BODY WITH SOAP AND WATER. BOTH THE STAFF MEMBER, AND THE PATIENT WHOSE BLOOD SPLATTERED ON THE STAFF MEMBER WERE SEEN BY INFECTION CONTROL, HAD BLOOD WORK DONE AND WERE PROVIDED WITH INFORMATION. THE FAULTY SYRINGES ARE IN THE PROCESS OF GETTING RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO INCIDENTS OF FAULTY 3ML ARTERIAL BLOOD SAMPLE 70 LU+200, SYRINGES. IN THE FIRST INCIDENT, THE NOZZLE/TIP SNAPPED COMPLETELY OFF UNDER PRESSURE FROM THE SYRINGE HITTING THE STAFF MEMBER IN THE CHEST AND THEN SPRAYED BLOOD UP HER FACE, COVERING HER LIPS AND GOING UP HER NOSE, AND COVERING HER CLOTHING. IN THE SECOND INCIDENT, HOLES WERE FOUND IN THE TIP OF THE SYRINGE LEAKING ONTO THE OPERATOR'S GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252579 3ML ARTERIAL BLOOD SAMPLE 70 LU+200/CA 3 ML SYRINGE IQG SIEMENS HEALTHCARE DIAGNOSTICS 4010060

    Patients

    Seq Age Sex Outcome Treatment
    1