BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARLOW 5MM HASSON STABLE CANNULA

    MDR report key: 1139 · Received August 18, 1992

    Report

    Report Number
    1139
    Event Type
    Malfunction
    Date Received
    August 18, 1992
    Date of Event
    June 25, 1992
    Report Date
    June 29, 1992
    Manufacturer
    MARLOW SURGICAL TECHNOLOGIES, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TIP PROTECTOR ON DEVICE DID NOT PROTRUDE OVER POINT AS ON PREVIOUS PRODUCTS AND DISLODGED IN PATIENT BECAUSE IT WAS NOT REMOVED PRIOR TO INSERTION. MFG. STATED AWARENESS OF QUALITY OF PRODUCT AND THAT AFTER REMAINDER OF PRODUCT WAS SOLD NEW PACKAGING WOULD OCCURDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: INADEQUATE QUALITY ASSURANCE, MANUFACTURING, TELEMETRY FAILURE. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLOW 5MM HASSON STABLE CANNULA UNKNOWN DQR MARLOW SURGICAL TECHNOLOGIES, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other