BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CWV DRAIN

    MDR report key: 6323 · Received August 16, 1993

    Report

    Report Number
    6323
    Event Type
    Malfunction
    Date Received
    August 16, 1993
    Date of Event
    May 23, 1993
    Report Date
    July 8, 1993
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    BYY
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 5/23/93 AN R.N. ATTEMPTED TO REMOVE JACKSON-PRATT DRAIN FROM PATIENT TIMES 3. PHYSICIAN NOTIFIED AND ATTEMPTED TO PULL OUT DRAIN AND TUBING BROKE OFF LEAVING HALF OF JP INSIDE. SET-UP STERILE FIELD, APPLIED LOCAL ANESTHESIA AROUND JP SITE AND ATTEMPTED TO REMOVE BUT WAS UNSUCCESSFUL UNDER LOCAL. PATIENT WAS INFORMED THAT SHE WOULD HAVE JP DRAIN REMOVED IN 1-2 WEEKS BY OUTPATIENT SURGERY. RETURNED ON 6/10/93 FOR REMOVAL OF JP DRAIN WITH NO COMPLICATIONSDEVICE 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CWV DRAIN NA BYY AXIOM MEDICAL, INC. NA 9301783

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other