BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 9701953 · Received February 12, 2020

    Report

    Report Number
    1036844-2020-00068
    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. VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. THE CUSTOMER DID PROVIDE PHOTOS THAT SHOW THE CORNER A KIT HAVING A CRACK. 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. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE OUTER TRAY AND KIT WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE CUSTOMER DID PROVIDE PHOTOS THAT SHOW A KIT WITH A CRACK IN THE OUTER TRAY. HOWEVER, WITHOUT THE ACTUAL SAMPLE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED.

    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
    163915 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F19J0104

    Patients

    Seq Age Sex Outcome Treatment
    1