BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWO-FER NEEDLES

    MDR report key: 1493712 · Received August 17, 2009

    Report

    Report Number
    1419106-2009-00019
    Event Type
    Malfunction
    Date Received
    August 17, 2009
    Date of Event
    March 10, 2009
    Report Date
    July 20, 2009
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER WAS CONTACTED FOR FURTHER INFO REGARDING THE REPORTED FAILURE MODE. THE CUSTOMER STATES THAT THE NEEDLES WERE USED FOR CHEMOTHERAPY AGENTS SUCH AS FLUOROURACIL. THE NEEDLES WERE PULLING FROM THE HUB RESULTING IN DRUG SPILLAGE. NO SYMPTOMS WERE EXHIBITED BY THE STAFF AND NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS ISSUE. THE PRODUCT FOR THIS COMPLAINT WAS RETURNED FOR EVAL ON 03/31/2009. A VISUAL INSPECTION SHOWED THAT THE CANNULA WAS FULLY SEPARATED FROM THE HUB. A PREVIOUS INVESTIGATION WAS CONDUCTED FOR A SIMILAR FAILURE MODE IN OCTOBER 2008, AFTER SAMPLE PRODUCT FAILED THE PULL TESTS DURING THE IN-PROCESS INSPECTION. IT WAS FOUND THAT THE MANUFACTURING EQUIPMENT FOR THIS PRODUCT WAS THE ROOT CAUSE. A REPAIR WAS PERFORMED TO THE EQUIPMENT ON 10/23/2008 AND ALL CONTROLLED/NON-RELEASED PRODUCTS THAT WERE BUILT PRIOR TO THE CORRECTION WERE SCRAPPED. THE PRODUCT FOR THIS COMPLAINT WAS MANUFACTURED PRIOR TO CORRECTING THE EQUIPMENT. IT IS HIGHLY PROBABLE THAT THE REPORTED FAILURE MODE WAS THE RESULT OF THE EQUIPMENT FAILURE. THERE HAVE BEEN NO SIMILAR COMPLAINTS FOR PRODUCTS BUILT AFTER THE CORRECTION WAS IMPLEMENTED. A HEALTH HAZARD EVAL WAS COMPLETED FOR THIS TYPE OF FAILURE MODE ON THIS PRODUCT. THE EVAL SHOWED A NEGLIGIBLE RISK OF ADVERSE HEALTH CONSEQUENCES THAT INDICATED A RECALL WAS NOT NEEDED. TWO-FER NEEDLES ARE TRANSFER NEEDLES THAT ARE USED TO MOVE DRUGS FROM ONE VIAL TO ANOTHER AND THERE IS NO EXPOSURE TO BLOOD BORNE PATHOGENS. CLINICAL USERS ARE TRAINED IN HANDLING AND DISPOSING OF SHARPS AND DRUG SPILLAGE, IN MAKING SURE STERILITY IS NOT COMPROMISED, OR NON-INTENDED PARTICULATE MATTER IS NOT INTRODUCED INTO THE CSP.

    Description of Event or Problem · 1

    THE MAUDE DATABASE WAS REVIEWED BY BAXA CORPORATION'S QUALITY DEPARTMENT ON 07/20/2009. (B)(6) WAS DISCOVERED IN REGARDS TO A TWO-FER NEEDLE DETACHING FROM THE HUB. BAXA'S CUSTOMER COMPLAINT SYSTEM WAS REVIEWED AND THE ASSOCIATED COMPLAINT WAS IDENTIFIED. THE CUSTOMER CONTACTED BAXA TECHNICAL SUPPORT ON (B)(6) 2009 ABOUT THIS FAILURE MODE AND STATED THAT THERE WAS NO PT INVOLVEMENT AND NO OPERATOR INJURY. THE CUSTOMER DID NOT INDICATE THAT THEY INTENDED TO SUBMIT A MEDWATCH AT THE TIME THE COMPLAINT WAS REPORTED. PRODUCT WAS RETURNED FOR EVAL. THIS MDR IS BEING FILED PER BAXA CORPORATION'S PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWO-FER NEEDLES TWO-FER NEEDLES LHI BAXA CORP. 19035 722466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA