BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 9936519 · Received April 8, 2020

    Report

    Report Number
    1036844-2020-00135
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 2, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND AMPULES WITH A POTENTIALLY RELEVANT FINDING. FOR MATERIAL # K-07800-005 (LIDOCAINE 5 ML SOLUTION), LOT # 23P19L0085, ACCORDING TO INCOMING INSPECTION RECORDS, (B)(4) OF (B)(4) AMPULES WERE OBSERVED BROKEN IN A BATCH OF 33600. THIS IS OUTSIDE OF THE PARAMETER FOR THIS DEFECT. FOR MATERIAL # K-05500-042A (SALINE 10 ML SOLUTION), LOT # 23P19L0271, ACCORDING TO INCOMING INSPECTION RECORDS, (B)(4) OF (B)(4) AMPULES WERE OBSERVED BROKEN 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 LIDOCAINE AND SALINE SOLUTION AMPULES. 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

    THE REPORT STATES: ANESTHESIA TECHNICIAN NOTIFIED ME THIS MORNING OF REPORTS FROM THE OB DIRECTOR OF (B)(4) KITS FROM SAME LOT WITH BROKEN VIALS.

    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

    THE REPORT STATES: ANESTHESIA TECHNICIAN NOTIFIED ME THIS MORNING OF REPORTS FROM THE OB DIRECTOR OF 2 KITS FROM SAME LOT WITH BROKEN VIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404792 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F20A0147

    Patients

    Seq Age Sex Outcome Treatment
    1