BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN JACKSON PRATT 10MM 3/4PR

    MDR report key: 6019359 · Received October 11, 2016

    Report

    Report Number
    1423537-2016-00049
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    August 18, 2016
    Report Date
    October 11, 2016
    Manufacturer
    CARDINAL HEALTH P.R. 218, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED AND FORWARDED ON TO THE MANUFACTURING FACILITY FOR INVESTIGATION. INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED. DURING A REVIEW OF OUR RECORDS IT WAS DISCOVERED THAT THIS REPORT WAS INADVERTENTLY NOT FILED DURING THE APPROPRIATE TIME FRAME.  AS A RESULT OF THIS REVIEW, THE REPORT IS BEING FILED  TODAY.

    Description of Event or Problem · 1

    (B)(6) FEMALE HAD FIRST POST-OP CLINIC VISIT. DURING ATTEMPT TO REMOVE 2 JP DRAINS, THEY SNAPPED OFF AND PORTION REMAINED IN PATIENT. PT UNDERWENT SURGERY THE NEXT DAY FOR REMOVAL. PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND REMOVAL OF RETAINED DRAINS UNDER GENERAL ANESTHESIA. NO COMPLICATIONS AND PATIENT WAS TO DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670556 DRAIN JACKSON PRATT 10MM 3/4PR APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY CARDINAL HEALTH P.R. 218, INC. SU130-1309 P1504640

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention