BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDLYTE 3ML SYRINGE

    MDR report key: 9922418 · Received April 3, 2020

    Report

    Report Number
    3002637618-2020-00014
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 9, 2020
    Report Date
    May 20, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    IQG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS REQUESTED THE REMAINING SYRINGES TO BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, MULTIPLE TIMES. THERE HAS BEEN NO COMMUNICATION FROM THE CUSTOMER. AN INVESTIGATION WILL NOT BE POSSIBLE. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED BY CLEANING THE AFFECTED AREAS. TESTS WERE RUN ON THOSE EXPOSED AND NO MEDICAL TREATMENT OR INTERVENTION WAS REQUIRED. NO LEAKAGE, CRACKS, OR DAMAGE WAS OBSERVED ON ANY OTHER SYRINGES OF THE SAME BATCH. SIEMENS HAS REQUESTED THAT THE REMAINING UNUSED SYRINGES BE RETURNED TO THE MANUFACTURER. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCIDENT WHERE A SYRINGE CHAMBER WAS CRACKED AND BLOOD SPURTED ONTO THE PATIENT AND OPERATOR. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389188 RAPIDLYTE 3ML SYRINGE RAPIDLYTE 3ML SYRINGE IQG SIEMENS HEALTHCARE DIAGNOSTICS 3691444

    Patients

    Seq Age Sex Outcome Treatment
    1