BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 9702068 · Received February 12, 2020

    Report

    Report Number
    1036844-2020-00072
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 3, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE OUTER TRAY AND KIT WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE OUTER TRAY OF THE KIT WAS DAMAGED. THE CUSTOMER RETURNED DAMAGED KIT. VISUAL EXAMINATION OF THE RETURNED KIT REVEALED THE LOWER LEFT AND RIGHT CORNERS OF THE OUTER TRAY ARE STRESSED AND THE LOWER LEFT CORNER WAS CRACKED UNDER THE FLANGE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE CUSTOMER ALSO PROVIDED PHOTOS THAT SHOW THE CORNER OF KIT HAVING A CRACK. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE INVESTIGATION SHOWS NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. PER THE MANUFACTURING SITE, ALL INCOMING OUTER TRAYS ARE VISUALLY INSPECTED FOR EVIDENCE OF STRESS MARKS PRIOR TO PACKAGING AS WELL AS EACH PACKAGED KIT IS INSPECTED AFTER SEALING AND PRIOR TO BEING PLACED INTO THE CORRUGATE CONTAINER. THE REPORTED COMPLAINT THAT A TRAY WAS CRACKED WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. VISUAL INSPECTION OF THE RETURNED KIT REVEALED THE LOWER LEFT AND RIGHT CORNER SHOWED SIGNS OF STRESS AND THE LEFT CORNER HAD A CRACK UNDER THE FLANGE. THE CUSTOMER ALSO PROVIDED PHOTOS THAT SHOW THE CORNER OF KIT HAVING A CRACK. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE OUTER TRAY AND KIT WITH NO RELEVANT FINDINGS. ALSO, THE OUTER TRAYS ARE 100% INSPECTED PRIOR TO AND AFTER PACKAGING. IT IS UNKNOWN HOW THE KIT WAS HANDLED DURING SHIPPING OR PRIOR TO USE. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THE TRAY'S CORNERS BEING STRESSED , AND CRACKING COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE HAVE BEEN AROUND 5 KITS THAT HAVE SHOWN UP RECENTLY EITHER WITH DAMAGE TO THE OUTER TRAY OR THE LID STOCK PARTIALLY TORN OFF, MAKING PRODUCT NOT STERILE FOR USE.

    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 THERE HAVE BEEN AROUND 5 KITS THAT HAVE SHOWN UP RECENTLY EITHER WITH DAMAGE TO THE OUTER TRAY OR THE LID STOCK PARTIALLY TORN OFF, MAKING PRODUCT NOT STERILE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161658 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F19J0104

    Patients

    Seq Age Sex Outcome Treatment
    1