BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2485267 · Received March 9, 2012

    Report

    Report Number
    2090040-2012-00007
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Report Date
    January 16, 2012
    Product Code
    OEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINALLY, WHEN THE COMPLAINT WAS REPORTED, THE USER FACILITY WOULD NOT RELEASE THE DEVICES TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. IT WAS UNKNOWN IF THE DEVICES WERE MISLABELED AT THE TIME AND THE DEVICES WERE NOT USED SO THERE WAS NO RISK TO THE PATIENT, SO SSS DETERMINED NOT TO FILE A MEDICAL DEVICE REPORT AT THAT TIME. HOWEVER, ON (B)(4) 2012, THE DEVICES WERE RETURNED FOR AN EVALUATION. SIX GUIDING CATHETERS WERE RETURNED FOR AN EVALUATION. STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICES THROUGH OUR OPEN-BUT-UNUSED PROCESS. THE LABELS OF ALL SIX DEVICES WERE EVALUATED AGAINST THE PHYSICAL DEVICE PROPERTIES, THE OM SPECIFICATION GUIDE, DEVICE HISTORY RECORDS, AND SSS'S ITEM DATABASE. THE INVESTIGATION SHOWED THAT ONE DEVICE HAD THE CORRECT PART NUMBER BUT IN THE PART DESCRIPTION THE DEVICE WAS LISTED AS A 7FR SIZE WHEN IT WAS ACTUALLY AN 8FR SIZE. ONE DEVICE HAD THE CORRECT PART NUMBER, BUT INCORRECT CURVE SIZE LISTED ON THE LABEL. THREE DEVICES HAD THE INCORRECT PART NUMBER LISTED ON THE LABEL AND ONE DEVICE WAS LABELED CORRECTLY. BASED OFF THE INVESTIGATION THE MOST LIKELY ROOT CAUSE FOR THE TWO DEVICES THAT HAD THE CORRECT PART NUMBER BUT INCORRECT PART DESCRIPTION INFORMATION WAS DUE TO AN OVERSIGHT DURING INTRODUCTION OF THE DEVICE TYPE INTO THE OPEN-BUT-UNUSED PROGRAM AS THIS PROCESS REQUIRES MANUAL ENTRY OF THE PART NUMBER AND DESCRIPTION INTO THE ITEM DATABASE. THE MOST LIKELY ROOT CAUSE FOR THE THREE DEVICES WITH THE INCORRECT PART NUMBERS WAS DUE TO OVERSIGHT SINCE THE DEVICE LABELS WERE LIKELY MISMATCHED UPON THEIR APPLICATION TO THE DEVICE PACKAGING. THE ITEM DATABASE HAS BEEN UPDATED AND RETRAINING WAS PERFORMED FOR PACKAGING AND PRE-STERILIZATION INSPECTION PERSONNEL. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDING CATHETERS WERE MISLABELED. THE DEVICES WERE NEVER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A DQY OEX LA8SAL20

    Patients

    Seq Age Sex Outcome Treatment
    1