BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 10128126 · Received June 8, 2020

    Report

    Report Number
    1036844-2020-00161
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 14, 2020
    Report Date
    May 14, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND SALINE SOLUTION AMPULE WITH A POTENTIALLY RELEVANT FINDING. FOR MATERIAL # K-05500-042A (SALINE 10 ML SOLUTION), LOT # 23P19L0271, ACCORDING TO INCOMING INSPECTION RECORDS, 3 OF 500 AMPULES WERE OBSERVED TO HAVE TIPS BROKEN OFF IN A BATCH OF 43200. THIS IS OUTSIDE OF THE PARAMETER FOR THIS DEFECT. 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 WITH A POTENTIALLY RELEVANT FINDING ON THE SALINE SOLUTION AMPULE. HOWEVER, 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 PRODUCT WAS RECEIVED WITH THE OUTER BOX INTACT BUT WHEN THEY OPENED THE CASE THEY SAW THAT THE BOTTLES OF SODIUM CHLORIDE HAD BROKEN, SPILLED, AND EVAPORATED ON THE TRAYS, RENDERING THEM UNUSABLE. THEY REPORTED 23F20A0137 AS THE LOT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE KIT 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 PRODUCT WAS RECEIVED WITH THE OUTER BOX INTACT BUT WHEN THEY OPENED THE CASE THEY SAW THAT THE BOTTLES OF SODIUM CHLORIDE HAD BROKEN, SPILLED, AND EVAPORATED ON THE TRAYS, RENDERING THEM UNUSABLE. THEY REPORTED 23F20A0137 AS THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591221 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F20A0137

    Patients

    Seq Age Sex Outcome Treatment
    1