BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS 1/2" TEMP PROBE CONNECTOR, NON-STERILE BULK PACK

    MDR report key: 55432 · Received September 19, 1996

    Report

    Report Number
    1828100-1996-00001
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    August 20, 1996
    Report Date
    September 19, 1996
    Manufacturer
    3M HEALTH CARE. SARNS AND CDI PRODUCTS
    Product Code
    DTL
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE CONNECTOR DEVELOPED A LEAK. THE LEAK OCCURRED BETWEEN THE STAINLESS STEEL AND THE PLASTIC, APPARENTLY DUE TO A LACK OF BONDING MATERIAL AT THIS SITE. APPROXIMATELY ONE LITER OF BLOOD WAS REPORTEDLY LOST AS A RESULT OF THIS LEAK. NO PT INJURY HAS BEEN REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS 1/2" TEMP PROBE CONNECTOR, NON-STERILE BULK PACK TEMPERATURE PROBE CONNECTOR DTL 3M HEALTH CARE. SARNS AND CDI PRODUCTS 98-0702-0073-2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention