BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 10098742 · Received May 28, 2020

    Report

    Report Number
    1036844-2020-00176
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 19, 2020
    Report Date
    May 20, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND THE AMPULES WITH A POTENTIALLY RELEVANT FINDING. FOR MATERIAL # K-07800-005 (LIDOCAINE 5 ML SOLUTION), LOT # 23P19L0085, ACCORDING TO INCOMING INSPECTION RECORDS, 4 OF 315 AMPULES WERE OBSERVED BROKEN IN A BATCH OF 33600. THIS IS OUTSIDE OF THE PARAMETER FOR THIS DEFECT. FOR MATERIAL # K-05500-042A (SALINE 10 ML SOLUTION), LOT # 23P19L0271, ACCORDING TO INCOMING INSPECTION RECORDS, 3 OF 500 AMPULES WERE OBSERVED TO HAVE TIPS BROKEN OFF IN A BATCH OF 43200. 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.

    Description of Event or Problem · 0

    THE REPORT STATES: THE ANESTHESIA PROVIDER OPENED THE TRAY TO DISCOVER TWO OF THE GLASS VIALS WERE BROKEN. HE WAS ABLE TO FIND ALL THE PIECES AND DISCARDED EVERYTHING APPROPRIATELY AFTER BRINGING TO MY ATTENTION. THE ANESTHESIA PROVIDER OPENED A SECOND TRAY TO DISCOVER ONE OF THE GLASS VIALS WAS BROKEN BUT HE COULD NOT FIND ALL THE PIECES. THE TOP WAS MISSING. HE DISCARDED EVERYTHING APPROPRIATELY AFTER BRINGING TO MY ATTENTION.

    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

    THE REPORT STATES: THE ANESTHESIA PROVIDER OPENED THE TRAY TO DISCOVER TWO OF THE GLASS VIALS WERE BROKEN. HE WAS ABLE TO FIND ALL THE PIECES AND DISCARDED EVERYTHING APPROPRIATELY AFTER BRINGING TO MY ATTENTION. THE ANESTHESIA PROVIDER OPENED A SECOND TRAY TO DISCOVER ONE OF THE GLASS VIALS WAS BROKEN BUT HE COULD NOT FIND ALL THE PIECES. THE TOP WAS MISSING. HE DISCARDED EVERYTHING APPROPRIATELY AFTER BRINGING TO MY ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560206 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F20A0130

    Patients

    Seq Age Sex Outcome Treatment
    1