BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI AVANTI+ TRANSRAD KIT 11CM

    MDR report key: 6192186 · Received December 20, 2016

    Report

    Report Number
    9616099-2016-00807
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 28, 2016
    Report Date
    January 17, 2017
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. THE DEVICE IS ANTICIPATED TO BE RETURNED FOR EVALUATION BUT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PARTICLES OR ANOMALIES WERE FOUND INSIDE THE PRODUCTS IN THE COMPANY¿S WAREHOUSE IN (B)(4). THE ISSUE WAS NOTED IN THE WAREHOUSE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REPORTED ¿FOREIGN MATERIAL - IN STERILE PACKAGE¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. ACCORDING TO THE INSTRUCTIONS FOR USE, ¿DO NOT USE IF PACKAGE IS OPEN OR DAMAGED.¿ BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF SIX REPORTS (9616099-2016-00800, 9616099-2016-00801, 9616099-2016-00802, 9616099-2016-00805, 9616099-2016-00806 AND 9616099-2016-00807) CORRESPONDING TO THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICLES OR ANOMALIES WERE FOUND INSIDE THE PRODUCTS IN THE COMPANY¿S WAREHOUSE IN (B)(4). THE ISSUE WAS NOTED IN THE WAREHOUSE. THE PRODUCTS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839673 SI AVANTI+ TRANSRAD KIT 11CM DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS DE MEXICO 504616Z 17298454

    Patients

    Seq Age Sex Outcome Treatment
    1