BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 4810712 · Received June 1, 2015

    Report

    Report Number
    3006425876-2015-00179
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EXAMINATION OF A RETURNED PRODUCT SAMPLE. THE CUSTOMER PROVIDED AN INTRODUCER NEEDLE ATTACHED TO A RAULERSON SYRINGE. MICROSCOPIC EXAMINATION OF THE NEEDLE HUB REVEALED MULTIPLE CRACKS. SOME OF THE CRACKS INTERSECTED THE HUB OPENING. A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. HOWEVER, THE PROBABLE CAUSE IS MANUFACTURING RELATED. SINCE THE NEEDLE HUB IS A PURCHASED COMPONENT, FURTHER INVESTIGATION HAS BEEN INITIATED WITH THE SUPPLIER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION IN THE ER, THE MD AT ANE NOTICED A CRACK ON THE INTRODUCER NEEDLE HUB MAKING IT IMPOSSIBLE TO USE. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351774 CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 71F14G0846

    Patients

    Seq Age Sex Outcome Treatment
    1