BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 8544907 · Received April 24, 2019

    Report

    Report Number
    3006425876-2019-00272
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 4, 2019
    Report Date
    April 4, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DHR REVIEW OF BATCH NUMBER 74F1703388 WAS PERFORMED AND NO RELEVANT ISSUES WERE FOUND. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED & INSPECTED ACCORDING TO OUR SPECIFICATIONS. ONE UNIT OF CATALOG NUMBER CA-000010-19 SNAPLOCK ASSY WAS RECEIVED FOR ANALYSIS. AFTER FUNCTIONAL INSPECTION SAMPLE WAS DISASSEMBLED AND WAS OBSERVED THE SOFT TUBE BENT (CA-000006-1). AFTER FUNCTIONAL INSPECTION THE SAMPLE WAS DISASSEMBLED AND SOFT TUBE CA-000006-19 WAS REVIEWED TO VERIFY THE LENGTH USING GAGE GO/NO GO NLC08991 (DUE DATE: 15-SEP-2019) AND NO ISSUES WERE FOUND. THE SOFT TUBE WAS IN THE MINIMUM. SAMPLE WAS TESTED IN PM-842 ACCORDING TO TP-000031 REV.02 (LEAK TEST FOR SNAPLOCK PRODUCT) AND PASS TEST. ADDITIONALLY, SAMPLE WAS TESTED IN FIXTURE FIX-716 (NLC08827 DUE DATE: APR-12-2020) ACCORDING TO WI-002685 REV.03 (CATHETER INSERTION TEST FOR SNAPLOCK PRODUCT) AND PASS TEST. SAMPLE WAS ALSO TESTED WITH THE CATHETER THAT WAS ARRIVED WITH THE SAMPLE AND THE CATHETERS AVAILABLE IN FACILITY (B)(4). IT WAS NOTICED A LITTLE OF RESISTANCE WHEN THE CATHETER WAS INTRODUCED INSIDE OF SNAPLOCK. A NONCONFORMANCE WAS OPENED TO IDENTIFY THE ROOT CAUSE AND CORRESPONDING CORRECTIVE ACTIONS. A RISK EVALUATION HAS BEEN GENERATED. CUSTOMER COMPLAINT IS CONFIRMED, THE UNIT HAD AN OCCLUSION. FOR THIS FAILURE MODE A NONCONFORMANCE WAS OPENED AND CORRECTIVE ACTIONS HAVE BEEN PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER COULD NOT BE INSERTED INTO THE SNAPLOCK ADAPTOR. THE CATHETER WAS REMOVED AND A NEW KIT WAS OPENED INSTEAD.

    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 CATHETER COULD NOT BE INSERTED INTO THE SNAPLOCK ADAPTOR. THE CATHETER WAS REMOVED AND A NEW KIT WAS OPENED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340470 EPIDURAL CATHETERIZATION KIT N/A, NOT FOR US MARKET CAZ ARROW INTERNATIONAL INC. 71F18C2185

    Patients

    Seq Age Sex Outcome Treatment
    1