BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 3181151 · Received June 21, 2013

    Report

    Report Number
    2015691-2013-20392
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K082139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    BOTTOM OF SHELF BOX WAS SOAKED IN GLUTARALDEHYDE. BOTTOM OF JAR HAD CRACKS. SOLUTION WAS OBSERVED INSIDE JAR. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS. DEVICE WAS NOT USED. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE GLUTARALDEHYDE JAR AND PACKAGING WERE RETURNED AND EVALUATED BY ENGINEERING, WHO CONFIRMED THE JAR WAS DAMAGED AND THE GLUTARALDEHYDE SOLUTION HAD LEAKED OUT. SIGNIFICANT CRACKS WERE OBSERVED ON THE BOTTOM OF THE JAR, WHICH WERE LARGE ENOUGH TO CAUSE A SEPARATION AT THE BASE. NO ADDITIONAL DAMAGE WAS OBSERVED TO THE JAR. THE LID OF THE JAR WAS CLOSED AND THE SHRINK WRAP WAS INTACT. MOST OF THE GLUTARALDEHYDE WAS STILL PRESENT INSIDE THE JAR. THE ROOT CAUSE OF THE OBSERVED DAMAGE ON THE GLUTARALDEHYDE JAR WAS MOST LIKELY DUE TO IMPROPER HANDLING. PREVIOUS LAB TESTS CONDUCTED BY ENGINEERING HAVE DEMONSTRATED THE BOTTOM OF THE GLUT JAR CAN CRACK IF DROPPED ON ITS BASE. THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING NON-CONFORMITIES IN THE RETURNED JARS. PER PRELIMINARY PACKAGING PROCEDURES, EACH JAR UNDERGOES A 100 PERCENT VISUAL INSPECTION TO ENSURE THERE ARE NO LEAKS FROM THE JAR. A DHR REVIEW CONFIRMS THAT THE JAR PASSED ALL INSPECTION POINTS FOR PRODUCT RELEASE. A REVIEW OF THE JAR LOT USED TO PACKAGE THE DEVICE FOUND NO NON-CONFORMANCES OR SCRAPS. ADDITIONALLY, ALL RECEIVING INSPECTORS WITHIN THE QUALITY ORGANIZATION AT EDWARDS ARE ALSO TRAINED IN PROPER HANDLING AND RECEIVING PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE FOUND THE SOLUTION HAD LEAKED FROM THE PACKAGE WHEN HE CHECKED THE STOCK ON (B)(4) 2013. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282162 EDWARDS PERICARDIAL PATCH PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ EDWARDS LIFESCIENCES 4700 R-11F2121

    Patients

    Seq Age Sex Outcome Treatment
    1