BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHNIEDER/NAMIC SYRINGE

    MDR report key: 102070 · Received June 25, 1997

    Report

    Report Number
    1317056-1997-00027
    Event Type
    Malfunction
    Date Received
    June 25, 1997
    Date of Event
    May 31, 1997
    Report Date
    June 9, 1997
    Manufacturer
    SCHNEIDER/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED POUCH REVEALED A PINHOLE IN THE TYVEK. THE WORK ORDER HISTORY DOCUMENTATION INDICATES THAT ALL SETUPS, LINE CLEARANCES, AND INSPECTIONS WERE PERFORMED. THE INCIDENT APPEARS TO BE ISOLATED WITH NO EVIDENCE OF MACHINE MALFUNCTION OR OPERATOR ERROR. THE PUNCTURE MAY HAVE OCCURRED AFTER FINAL INSPECTION. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED-THERE IS A HOLE (UNDER 1 ID MM) AT PRIMARY PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHNIEDER/NAMIC SYRINGE 100CC ANGIOGRAPHIC SYRINGE DXT SCHNEIDER/NAMIC NA 395960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA