BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAMAX HANDLE KIT TROCAR/BEVEL 11GX12CM

    MDR report key: 1667419 · Received April 16, 2010

    Report

    Report Number
    1625685-2010-00015
    Event Type
    Malfunction
    Date Received
    April 16, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 16, 2010
    Manufacturer
    CAREFUSION
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE COMPLAINT SAMPLE CONFIRMED THE REPORTED FAILURE MODE. INSPECTION OF THE CANNULA HUB/CAP JOINT NOTED LACK OF ADHESIVE IN THE JOINT, THUS RESULTING IN A WEAKER BOND BETWEEN THE CANNULA AND THE CAP. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES IDENTIFIED A SPECIFIC STEP IN THE MANUFACTURING PROCESS FOR THE DISPENSING OF ADHESIVE AT THE CANNULA HUB/CAP JOINT AND THE SUBSEQUENT PLACEMENT OF THE CAP ON THE HUB. THE ADHESIVE IS MANUALLY DISPENSED USING VISUAL VERIFICATION TO ENSURE A SUFFICIENT AMOUNT OF ADHESIVE HAS BEEN APPLIED. A REVIEW OF THE CURRENT MANUFACTURING PROCESS AND APPLICABLE QUALITY PLAN FOR THIS STYLET ASSEMBLY DETERMINED THAT THE PROCESS IS ADEQUATE AND APPROPRIATE FOR THE PROPER ASSEMBLY OF THE APPLICABLE STYLET COMPONENT. HOWEVER, BASED ON THIS REPORTED ISSUE ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL RECEIVE REMEDIAL TRAINING REGARDING THE CURRENT ASSEMBLY PROCEDURES IN ORDER TO REINFORCE THE PROPER MANUFACTURING TECHNIQUES FOR THIS ASSEMBLY.

    Description of Event or Problem · 1

    DURING A VERTEBROPLASTY, THE HANDLE OF THE STYLET BROKE OFF OF THE NEEDLE. THE PHYSICIAN WAS ABLE TO REMOVE THE STYLET WITHOUT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAMAX HANDLE KIT TROCAR/BEVEL 11GX12CM AVAMAX HANDLE KIT TROCAR/BEVEL 11GX12CM KIH CAREFUSION VPH0011 L9J309

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other