BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN JACKSONPRATT FL7MM3/4 PE

    MDR report key: 2882640 · Received December 20, 2012

    Report

    Report Number
    1423537-2012-00048
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 20, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SAMPLE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, A PICTURE OF THE SAMPLE WAS SENT FOR REVIEW. UPON EVALUATION OF THE PICTURE IT WAS NOTICED THAT THE FRACTURE OCCURRED AT THE UNPERFORATED WHITE FLAT SECTION. IT ALSO SHOWED TRACES OF BODY FLUID AND A PIECE OF BLACK SUTURE THREAD ATTACHED TO THE TUBING. THE CHARACTERISTICS OF THE FRACTURED AREA ARE SIMILAR TO THOSE FAILURES, WHICH ARE CAUSED BY SOME ABRASION OR SCORING WITH SHARP INSTRUMENTS ON THE TUBE SURFACE. THE SAMPLE IN THE PICTURE WAS OBSERVED TO EXHIBIT REMNANT EDGES MORE CONSISTENT WITH TEAR PROPAGATION THAN WITH STRESS FRACTURE. THE DEVICE HISTORY RECORD FOR THE FINISHED GOOD WAS REVIEWED AND NO INCIDENT WAS DOCUMENTED THAT COULD HAVE CAUSED THIS TYPE OF NON-CONFORMANCE. NO REPORTED NON-CONFORMANCES WERE FOUND FROM REVIEW OF THE RECORDS, WHICH INCLUDED INCOMING AND IN-PROCESS INSPECTION, NON-CONFORMING REPORTS AND MANUFACTURING RECORDS. THE MINIMUM PULL TEST SPECIFICATION FOR THIS DRAIN IS 5.0 LB. DHR DEMONSTRATED PULL TEST RESULTS OF A MINIMUM OF 14.3 LB (DRAIN/TUBING JUNCTION AREA) AND 11.7 LB (PERFORATED AREA) IN QUALITY TESTING PERFORMED. INSPECTION RECORD FOR THE RAW MATERIALS USED TO MOLD THE FLAT SECTION WAS REVIEWED AND (B)(4) INDICATES THAT ALL TEST RESULTS ARE WITHIN SPECIFICATION LIMITS, INCLUDING TENSILE AND TEAR TESTS. THIS IS THE FIRST COMPLAINT RECEIVED ON THIS CATALOG IN THE LAST 12 MONTHS. THE LOT NUMBER REPORTED WAS MANUFACTURED ON JULY 16, 2012. ROOT CAUSE FOR THE REPORTED CONCERN CANNOT BE IDENTIFIED WITH THE AMOUNT OF INFORMATION AVAILABLE. AS PREVENTIVE ACTIONS, THE CUSTOMER WILL BE PROVIDED WITH A COPY OF INSTRUCTIONS FOR USE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). "DRAINS OR TUBING SHOULD NOT BE HANDLED WITH ANY INSTRUMENTS. THIS CAN LEAD TO TEARING, WARPING, OR WEAKENING AND SUBSEQUENT BREAKAGE OF THE DRAIN. TO FACILITATE REMOVAL OF THE DRAIN, THE DRAIN AND TUBING PORTIONS SHOULD NOT BE CURLED, PINCHED, OVER-STRETCHED OR SUTURED; EITHER INTERNALLY OR EXTERNALLY. DO NOT SUTURE THE DRAIN(S). DRAINS SHOULD BE PLACED AND REMOVED CAREFULLY BY HAND ONLY WITH A SLOW, STEADY PRESSURE. EXCESSIVE FORCE MAY RESULT IN BREAKAGE.

    Description of Event or Problem · 1

    DRAIN IN THE PATIENT TORE AND WAS RETAINED IN THE PATIENT TEMPORARILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN JACKSONPRATT FL7MM3/4 PE DRAIN GBX CARDINAL HEALTH SU130-1308 1120877

    Patients

    Seq Age Sex Outcome Treatment
    1 Other