BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2862 · Received July 2, 1992

    Report

    Report Number
    2862
    Event Type
    Malfunction
    Date Received
    July 2, 1992
    Date of Event
    December 17, 1991
    Report Date
    December 18, 1991
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    FFA
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT TO THE OPERTING ROOM ON DECEMBER 16, 1991 FOR REMOVAL OF HARDWARE FROM NECK AND ARTHROSCOPY WAS DONE ON RIGHT WRIST. A NUMBER 10 BLAKE DRAIN WAS INSERTED IN RIGHT SIDE OF NECK ON 12/17/91. THE DOCTOR ORDERED THE DRAIN TO BE REMOVED. NURSES MET RESISTANCE WHEN TAKING OUT DRAIN. THEY CALLED THE DOCTOR WHO SAID THAT THE RESISTANCE WAS DUE TO THE FACT THAT THE TIP END WAS SLIGHTLY LARGER. WHEN THE NURSE PULLED AGAIN, THE DRAIN TUBE BROKE OFF LEAVING THE END IN THE PATIENT. THE PATIENT WAS RETURNED TO OR ON 12/17/91 FOR REMOVAL AND THEN DISCHARGED FROM HOSPITAL 12/18/91DEVICE 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: VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN Implant DRAIN FFA JOHNSON & JOHNSON N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other