BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALEM SUMP TUBE

    MDR report key: 75972 · Received March 12, 1997

    Report

    Report Number
    9611018-1997-00001
    Event Type
    Malfunction
    Date Received
    March 12, 1997
    Report Date
    February 10, 1997
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES WERE RETURNED AND CONFIRMED TO HAVE NO EYES. LOT HISTORY RECORDS DISPLAYED NO EVIDENCE OF THE DEFECT. MFG OPENED AN INVESTIGATION AND DETERMINED PROBLEM WAS DUE TO OPERATOR ERROR. INTENSIVE RETRAINING WAS DONE IN 11/1994. THIS LOT WAS PRODUCED PRIOR TO RETRAINING.

    Description of Event or Problem · 1

    THE TUBE CONTAINED NO EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALEM SUMP TUBE DRAINAGE TUBE KNT SHERWOOD DAVIS AND GECK NA 94G039T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN