BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MIX EMPTY EVA CONTAINER

    MDR report key: 1692254 · Received January 14, 2010

    Report

    Report Number
    1419106-2010-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    October 28, 2009
    Report Date
    November 16, 2009
    Manufacturer
    BAXA CORP.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT REPORTED FOR THIS COMPLAINT; THEREFORE, DATE OF MANUFACTURE AND (B)(4) HISTORY COULD NOT BE REVIEWED. BECAUSE USER FACILITY INFO IS UNK, NO FOLLOW-UP CAN BE PERFORMED REGARDING THIS COMPLAINT. NO PRODUCT WAS RETURNED AND NO FURTHER EVAL CAN BE PERFORMED. A REVIEW OF RISK DOCUMENTATION FOR THE REPORTED FAILURE WAS CONDUCTED AND IT WAS DETERMINED THAT THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED FOR THE DEVICE. THE PRODUCT MUST PASS (B)(4) TESTING AND BAXA DEFINED TESTING FOR DROP TEST RESISTANCE. AT THIS TIME, THIS IS THE ONLY COMPLAINT FOR THS ISSUE. BAXA WILL CONTINUE TO MONITOR THIS TYPE OF REPORT TO DETERMINE IF CORRECTIVE ACTION IS INDICATED IN THE FUTURE. CONCLUSION - NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE MAUDE DATABASE WAS REVIEWED ON (B)(6) 2009 AND MEDWATCH REPORT NUMBER (B)(4) WAS DISCOVERED. THIS MDR IS BEING FILED PER BAXA CORPORATION'S PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED. THE COMPLAINT DATABASE WAS REVIEWED; A CUSTOMER COMPLAINT FOR THIS FAILURE WAS NOT RECEIVED BY BAXA PRIOR TO THIS REPORT. A COMPLAINT WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. MEDWATCH (B)(4) DESCRIPTION: " A CENTRAL VENOUS NUTRITION (B)(4) BAG FOR THE PT WAS HUNG ON THE IV POLE. THE MATERIAL OF THE BAG WAS DIFFERENT AND WEAKER THAN PREVIOUS BAGS USED FOR (B)(4). THE HOLE FOR HANGING THE BAG ONTO THE IV POLE TORE UNDER THE STRAIN OF THE (B)(4) OF FLUID WEIGHT. ABOUT 1/3 OF THE LIQUID IN THE BAG DRAINED OUT DUE TO THE FALL OF THE BAG AND TEAR OF THE IV TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX EMPTY EVA CONTAINER EXACTA-MIX EMPTY EVA CONTAINER KPE BAXA CORP. 740

    Patients

    Seq Age Sex Outcome Treatment
    1