BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ANES/EPIDURAL CATH KIT

    MDR report key: 9868420 · Received March 23, 2020

    Report

    Report Number
    1036844-2020-00095
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND SALINE AMPULE 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 DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL KIT AND SALINE AMPULE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THE BROKEN AMPULE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GLASS VIAL OF SALINE WAS BROKEN WITHIN THE KIT.

    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 THE GLASS VIAL OF SALINE WAS BROKEN WITHIN THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329190 SPINAL ANES/EPIDURAL CATH KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F19L0282

    Patients

    Seq Age Sex Outcome Treatment
    1