BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")

    MDR report key: 4109113 · Received September 8, 2014

    Report

    Report Number
    1036844-2014-00353
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    BSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE PHOTOGRAPH OF THE SHIPPING PAPERS AND THE LIDSTOCK OF THE DEVICE FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PHOTOGRAPH REVEALED THAT THE LIDSTOCK OF THE POUCH INDICATES THAT THE CONTENTS OF THE POUCH INCLUDE A 17 GAUGE NEEDLE. BASED ON THE BILL OF MATERIALS OF THE POUCH IN AGILE, AND IT WAS CONFIRMED THAT THE POUCH SHOULD CONTAIN AN 18 GAUGE NEEDLE. THE CONTENTS OF THE LOT NUMBER PROVIDED, RF2096425, INDICATED THAT PART NUMBER K-18040-001 WAS PACKAGED IN THIS KIT WHICH IS THE CORRECT PART; AND 18 GAUGE NEEDLE. THE LOT NUMBER CONTENTS ALSO CONFIRMED THAT LOT NUMBER WAS PACKAGED WITH THE SUBSTITUTION LIDSTOCK, PART NUMBER B-18040-132A. A REVIEW OF THE ARTWORK FOR THIS LIDSTOCK IN AGILE CONFIRMED THAT THE LIDSTOCK IS DESIGNED WITH THE INCORRECT NEEDLE INFO. THE PRIMARY LIDSTOCK ARTWORK WAS ALSO REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. A REVIEW OF THE PRIMARY LIDSTOCK REVEALED THAT THE PRIMARY LIDSTOCK IS DESIGNED WITH THE CORRECT INFO. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE POUCH WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE COMPLAINT (INCORRECT LABEL) IS CONFIRMED. THE POTENTIAL ROOT CAUSE IS LABELING. A NONCONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CONTENTS LABEL INDICATES 17GA AND IT SHOULD BE 18GA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551411 ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2") NERVE BLOCK NEEDLE BSP ARROW INTL., INC. RF2096425

    Patients

    Seq Age Sex Outcome Treatment
    1