BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SETS

    MDR report key: 11995382 · Received June 14, 2021

    Report

    Report Number
    1036844-2021-00109
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 31, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    UDI-DI
    20801902070177
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (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 CATHETER WITH NO RELEVANT FINDINGS. 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 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 CATHETER WITH NO EVIDENCE TO INDICATE A MANUFACTURING RELATED ISSUE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    ANOTHER NEW ISSUE THAT JUST CAME UP LAST NIGHT IS, WE HAD A DEFECTIVE EPIDURAL CATHETER; IT HAD NO PERFORATIONS IN THE END, SO NO MEDICATION COULD BE ADMINISTERED THROUGH IT. THIS REQUIRED A REPEAT EPIDURAL PROCEDURE AND DELAYED PATIENT CARE.

    Additional Manufacturer Narrative · 1

    QN#(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

    ANOTHER NEW ISSUE THAT JUST CAME UP LAST NIGHT IS, WE HAD A DEFECTIVE EPIDURAL CATHETER; IT HAD NO PERFORATIONS IN THE END, SO NO MEDICATION COULD BE ADMINISTERED THROUGH IT. THIS REQUIRED A REPEAT EPIDURAL PROCEDURE AND DELAYED PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886858 EPIDURAL CATHETERIZATION SETS ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. IPN040178 UNKNOWN 20801902070177

    Patients

    Seq Age Sex Outcome Treatment
    1