BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 9695897 · Received February 11, 2020

    Report

    Report Number
    1036844-2020-00065
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 24, 2020
    Report Date
    January 28, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM SALES HISTORY DATA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. ALTHOUGH, THE CUSTOMER PROVIDED A PHOTO THAT CLEARLY SHOWS A BENT TIP, WITHOUT THE ACTUAL SAMPLE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. HOWEVER, THE REPORTED COMPLAINT OF A NEEDLE TIP WAS BENT WAS CONFIRMED BASED ON A PHOTO PROVIDED FROM THE CUSTOMER. VISUAL EXAMINATION OF THE CUSTOMER PROVIDED PHOTO CLEARLY SHOWS AN EPIDURAL NEEDLE WITH A BENT TIP. A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM SALES HISTORY DATA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICIAN WAS ATTEMPTING TO INSERT THROUGH THE LIGAMENT AND NEEDLE TIP BENT.

    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 THE CLINICIAN WAS ATTEMPTING TO INSERT THROUGH THE LIGAMENT AND NEEDLE TIP BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154978 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1