BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN JACKSON PRATT DRAIN

    MDR report key: 4906504 · Received July 10, 2015

    Report

    Report Number
    1423537-2015-00047
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 14, 2015
    Report Date
    July 10, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SAMPLE WAS RECEIVED FOR INVESTIGATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE SHOWED THAT IT IS A 13.62 INCHES IN LENGTH PORTION OF JACKSON-PRATT SILICONE ROUND DRAIN 15FR. WE ALSO RECEIVED A JP 100CC BULB RESERVOIR LOOSE IN THE PLASTIC BAG. VISUAL INSPECTION REVEALED THAT THE SILICONE TUBING BROKE OFF AT UNPERFORATED TUBING SECTION. MICROSCOPIC EXAMINATION REVEALED WAVY/JAGGED EDGE AT THE TUBING FRACTURE SITE AND NO DISTORTION AND/OR TEARS IN THE ADJACENT PORTION DRAIN, WHICH SUGGESTS THAT THE DRAIN WAS NOT STRETCHED (ELONGATED) TO FAILURE. THE CHARACTERISTICS OF THE FRACTURED AREA AND THE ABSENCE OF ANY TUBING DISTORTION ARE SIMILAR TO THOSE FAILURES, WHICH ARE CAUSED BY PUNCTURE BY A SHARP INSTRUMENT ON THE TUBING SURFACE. AS NO LOT NUMBER WAS PROVIDED, WE WERE UNABLE REVIEW THE DEVICE HISTORY RECORD FOR QUALITY TESTING PERFORMED DURING MANUFACTURING AND THE CORRESPONDING RESULTS. AN ANALYSIS OF THE COMPLAINTS DATA SINCE JULY 2014 TO PRESENT DEMONSTRATES THAT THIS IS THE FIRST TIME THAT THIS TYPE OF ISSUE IS REPORTED FROM UNKNOWN JP DRAIN CATALOG, ALTHOUGH FOUR (4) INCIDENTS FOR THE SAME CONDITION FROM OTHER CATALOGS WERE REPORTED. THE NON-CONFORMANCE REPORT DATA WAS ALSO REVIEWED FOR THE SAME TIME PERIOD AND NO ISSUES THAT COULD BE RELATED TO THE CONDITION REPORTED WERE FOUND. THE MOST PROBABLE ROOT CAUSE WAS IDENTIFIED AS MISUSE BY THE CUSTOMER SINCE THE WAVY/JAGGED EDGE CONDITION OBSERVED AT THE FRACTURE AREA SUGGESTS THAT AN INSTRUMENT WAS USED TO HANDLE THE PRODUCT WHICH MAY HAVE DAMAGE THE PRODUCT THUS LEADING TO TUBING BREAKAGE. IT IS ALSO RECOMMENDED TO STRICTLY FOLLOW THE INSTRUCTIONS PROVIDED IN THE INSTRUCTION FOR USE DATA INCLUDED WITH THE PRODUCT TO ENSURE DRAINS ARE PROPERLY USED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE RECEIVED SAMPLE IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    RN WAS TRAINING PATIENT TO STRIP TUBING AND IT FRACTURED ABOUT 2" FROM THE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449360 UNKNOWN JACKSON PRATT DRAIN DRAIN GBX CARDINAL HEALTH UNKJP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention