BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITUBES

    MDR report key: 3682935 · Received February 21, 2014

    Report

    Report Number
    3002807968-2014-00007
    Event Type
    Injury
    Date Received
    February 21, 2014
    Date of Event
    January 19, 2014
    Report Date
    May 2, 2017
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    GIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS FOUND DURING AN INTERNAL REVIEW AT RADIOMETER MEDICAL ON (B)(6) 2017; INFORMATION ABOUT THE POTENTIAL RISK OF INFECTION FROM THE PATIENT HAS BEEN RECEIVED FROM THE CUSTOMER, WHICH STATES THAT THE PATIENT WAS NOT IN ISOLATION FOR ANYTHING CONTAGIOUS.

    Additional Manufacturer Narrative · 1

    TEST OF THE BREAKING FORCE OF CLINITUBES FROM THE REFERENCE STOCK OF LOT JV-02 HAS BEEN PERFORMED AND COMPARED TO THE BREAKING FORCE OF THE PREVIOUS AND FOLLOWING LOTS PRODUCED (JW-01 AND JT-01). THE BREAKING FORCE OF LOT JV-02 WAS NOT STATISTICALLY DIFFERENT FROM THE BREAKING FORCE OF LOT JW-01 OR JT-01, AND NO OTHER COMPLAINTS REGARDING THIS LOT HAVE BEEN RECEIVED. SINCE THESE CLINITUBES ARE MADE OF GLASS THERE IS A RISK THAT THEY CAN BREAK. THE HOSPITAL HAS NOW CHANGED TO USE SAFE CLINITUBES (MADE OF PLASTIC) TO AVOID THIS PROBLEM IN THE FUTURE. INFORMATION ABOUT THE POTENTIAL RISK OF INFECTION FROM THE INFANT HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    WHEN THE USER (TECHNICIAN) WAS DRAWING BLOOD FROM AN INFANT THE CAPILLARY BROKE WHEN THE END CAP WAS BEING PUT ON. THE USERS LEFT MIDDLE FINGER WAS PUNCTURED. GLOVES WERE WORN. THE REPORT STATES THAT THE USER WAS TREATED AND RELEASED FROM THE ED AND SENT HOME. NO SPECIFIC INFORMATION REGARDING THE TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110545 CLINITUBES GLASS CAPILLARY TUBES GIO RADIOMETER MEDICAL APS D957G-70-125 JV02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other