BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET NRFIT

    MDR report key: 9701852 · Received February 12, 2020

    Report

    Report Number
    3006425876-2020-00169
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    February 1, 2020
    Report Date
    February 4, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON POTENTIAL LOT NUMBERS PROVIDED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR NR FIT SYRINGE WITH NO RELEVANT FINDINGS. A REVIEW OF DESIGN CHANGE HISTORY FOR KIT OT19TKPSS AND PART NUMBER: KZ-05501-002N WAS PERFORMED AS A PART OF THIS INVESTIGATION. NO DESIGN CHANGES HAVE BEEN MADE TO THIS PRODUCT IN THE PAST TWO YEARS THAT WOULD HAVE LED TO THIS COMPLAINT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS PROVIDED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON POTENTIAL LOT NUMBERS PROVIDED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR NR FIT SYRINGE WITH NO RELEVANT FINDINGS. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOR SYRINGE CONTAINED IN THE PDK SET FALLS APART DURING USE.

    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

    IT WAS REPORTED THAT THE LOR SYRINGE CONTAINED IN THE PDK SET FALLS APART DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160896 EPIDURAL CATHETERIZATION SET NRFIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. IPN048027 UNKN

    Patients

    Seq Age Sex Outcome Treatment
    1