BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT: 19 GA X 35

    MDR report key: 8353783 · Received February 20, 2019

    Report

    Report Number
    1036844-2019-00112
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 26, 2019
    Report Date
    January 27, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE AND EPIDURAL KIT WITH NO RELEVANT FINDINGS. THE PACKAGING CONFIGURATION FOR THE KIT WAS REVIEWED AND THE LOR SYRINGE IS LOCATED IN A TRAY CAVITY THAT IS SEPARATED FROM OTHER COMPONENTS. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. HOWEVER, THE REPORTED COMPLAINT OF THE LOR SYRINGE CAME APART WAS CONFIRMED BASED ON A PHOTO PROVIDED FROM THE CUSTOMER. VISUAL EXAMINATION OF THE CUSTOMER PROVIDED PHOTOS CLEARLY REVEAL A BROKEN AND DAMAGED LOR SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE AND THE EPIDURAL KIT WITH NO RELEVANT FINDINGS. IT IS UNKNOWN HOW THE LOR SYRINGE WAS HANDLED PRIOR TO USE. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THE LOR SYRINGE COMING APART COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PROVIDER ATTACHED THE GLASS LOR LUER SLIP SYRINGE, THE SYRINGE BROKE AND CAME APART.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PROVIDER ATTACHED THE GLASS LOR LUER SLIP SYRINGE, THE SYRINGE BROKE AND CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147245 EPIDURAL CATHETERIZATION KIT: 19 GA X 35 ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. SF18K8279

    Patients

    Seq Age Sex Outcome Treatment
    1