BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIDS KIT (TM) 18" ADD-ON BLOOD SAMPLING KIT

    MDR report key: 5323401 · Received September 21, 2004

    Report

    Report Number
    1526863-2004-00071
    Event Type
    Malfunction
    Date Received
    September 21, 2004
    Date of Event
    August 18, 2004
    Report Date
    August 18, 2004
    Manufacturer
    MEDEX
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT SAMPLES WOULD BE RETURNED HOWEVER HAS NOT BEEN RECEIVED AS OF YET. THE USER REPORTED MULTIPLE LOT NUMBERS WERE AVAILABLE ON THE FLOOR AT THE TIME OF THE INCIDENT. THE LOT NUMBERS WERE 33C270062, 33E050044, AND 33D250039. THESE LOTS WERE MANUFACTURED 03/01/2003, 04/01/2003, AND 05/01/2003. THE BREAKAGE COULD NOT BE DETERMINED WITHOUT RETURNED PRODUCT HOWEVER THROUGH IN HOUSE TESTING IT APPEARS THAT THE BREAKAGE IS MOST LIKELY DUE TO A SMALLER INTERNAL DIAMETER ON THE SAMPLING SITE BODY AND OVER TIME THE BODY IS EXPANDING AND CRACKING. THE ORBITAL PROCESS USED TO SECURE THE SITE IN THE BODY WAS REVIEWED WITH NO ISSUES PRESENT. THE SAMPLING SITE BODY HAS BEEN REVISED OVER THE LAST YEAR TO ALLOW FOR EASE OF INSERTION OF THE SAMPLING SITE. WE BELIEVE THAT THE CHANGE TO THE BODY WILL ADDRESS THIS ISSUE. THE LOT NUMBERS IN QUESTION WERE MANUFACTURED PRIOR TO THE CHANGE TO THE BODY. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES PRESENT. MEDEX WAS UNABLE TO CONFIRM THIS ISSUE HOWEVER CAN DETERMINE THE POSSIBLE CAUSE. NO ADDITIONAL ACTION NECESSARY AT THIS TIME. MEDEX CONSIDERS THIS ISSUE CLOSED WITH THIS MDR REPORT. MEDEX RECOGNIZES THAT THIS REPORT IS NOT BEING SUBMITTED WITHIN THE REQUIRED TIMEFRAME. MDR REPORTING DEADLINE BASED UPON THE DATE THE INFORMATION WAS RECEIVED WAS SEPTEMBER 17, 2004. MEDEX CONTINUES TO BE COMMITTED TO REGULATORY COMPLIANCE AND WILL TAKE STEPS TO ENSURE THAT THIS DOES NOT RECUR. .

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE BEDS WERE FOUND WET DUE TO THE PRODUCTS LEAKING DUE TO CRACKS IN THE SITES. THE CRACKS HAVE BEEN FOUND IN THE PACKAGE. AT PRIMING AND ON PATIENTS. THERE WAS NO PATIENT INJURY OR TREATMENT AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIDS KIT (TM) 18" ADD-ON BLOOD SAMPLING KIT CLOSED BLOOD SAMPLING KIT CBT MEDEX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK