BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T THORACENTESIS TRAY 14G DRUG FREE

    MDR report key: 4241543 · Received November 10, 2014

    Report

    Report Number
    1625685-2014-00140
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 9, 2014
    Report Date
    January 5, 2015
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) UNIT OF PRODUCT CATALOG CODE 4341BSDF, LOT NUMBER 0000623422, WAS RECEIVED FOR EVALUATION. THROUGH EXAMINATION AND LEAK TESTING OF THE COMPLAINT SAMPLE, THE INVESTIGATION WAS ABLE TO CONFIRM THE REPORTED FAILURE MODE AS THE CATHETER ASSEMBLY LEAKS THROUGH THE HOUSING TOP PORT. THIS FAILURE MODE IS OBSERVED WHEN THE RADIOPAQUE CATHETER IS NOT POSITIONED CORRECTLY INSIDE THE HOUSING DURING ASSEMBLY, POTENTIALLY LEAVING AN OPENING INSIDE THE ASSEMBLY AND LEADING TO THE FAILURE MODE EXPERIENCED BY THE USER. A DEVICE HISTORY RECORD (DHR) REVIEW, RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. A REVIEW OF THE WORK INSTRUCTIONS FOR THE THORACENTESIS CATHETER ASSEMBLY NOTED THE INSPECTION OF THE ASSEMBLY IS A VISUAL INSPECTION PROCESS. THE WORK INSTRUCTIONS INCLUDE SEVERAL INDICATIONS ENSURING THE OPERATOR INSPECTS THE ASSEMBLY ADEQUATELY. A REVIEW OF APPLICABLE INSPECTION METHODS IDENTIFIED SPECIFIC INSPECTION STEPS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES IDENTIFIED SPECIFIC MANUFACTURING STEPS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THIS FAILURE MODE WAS IDENTIFIED AS AN OPERATOR ERROR DURING THE ASSEMBLY OF THE CORRESPONDING THORACENTESIS CATHETER ASSEMBLY. THE INVESTIGATION DETERMINED THAT SOME ASSEMBLY PROCESSES/METHODS MAY LEAD TO THE INCORRECT ASSEMBLY OF THE THORACENTESIS CATHETER. THE PROCESS IS BEING EVALUATED AND ADDITIONAL TRAINING HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    HOLES UPON INSERTION OF THE TUBE AIR WAS PASSING THROUGH THE CATHETER INTO THE SYRINGE. A SECOND SAFE-T THORACENTESIS TRAY WAS USED WITH NO COMPLICATIONS. AFTER THE PROCEDURE THE CATHETER WAS FLUSHED AND IT WAS FOUND THAT FLUID PASSED THROUGH THE ADDITIONAL ( PROXIMAL ) PORT, NOT THROUGH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722565 SAFE-T THORACENTESIS TRAY 14G DRUG FREE NEEDLE, CATHETER GCB CAREFUSION 4341BSDF 0000623422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other