BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 10014688 · Received April 30, 2020

    Report

    Report Number
    1036844-2020-00140
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 11, 2020
    Report Date
    April 13, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND AMPULES WITH A POTENTIALLY RELEVANT FINDING. FOR MATERIAL # K-07900-001 (LIDOCAINE W/EPINEPHRINE 5 ML), LOT # 23P19L0082, ACCORDING TO INCOMING INSPECTION RECORDS, 1 OF 315 AMPULES WERE OBSERVED BROKEN IN A BATCH OF 19200. THIS IS OUTSIDE OF THE PARAMETER FOR THIS DEFECT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 KITS FROM SAME LOT WITH BROKEN VIALS. THE REPORTER WAS UNABLE TO LOCATE THE KITS AT TIME OF REPORT.

    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 2 KITS FROM SAME LOT WITH BROKEN VIALS. THE REPORTER WAS UNABLE TO LOCATE THE KITS AT TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478305 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F19M0106

    Patients

    Seq Age Sex Outcome Treatment
    1