BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 2802895 · Received October 24, 2012

    Report

    Report Number
    9616099-2012-00609
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT WHITISH FOREIGN MATTER WAS FOUND INSIDE OF THE STERILE POUCH OF THE 6F .070 XB 3.5 100CM VISTA BRITE TIP GUIDING CATHETER (GC) DURING INCOMING VISUAL CHECK PROCESS AT THE WAREHOUSE. THE OUTER PRODUCT BOX AND STERILIZED POUCH WERE INTACT, AND THE SEAL OF THE POUCH WAS NOT OPEN. THE ACTUAL PRODUCT HAD NO DAMAGE. THERE WERE NO ANOMALIES EXCEPT FOR THIS FAILURE. THE PRODUCT HAD BEEN ALREADY IN THIS CONDITION WHEN IT WAS DELIVERED. THE PRODUCT WAS HANDLED AND STORED AS PER THE USUAL PROCEDURE. IT WAS NOT SHIPPED OUT OF THE WAREHOUSE AND WAS NOT CLINICALLY USED. THE PRODUCT WAS NEITHER RE-STERILIZED NOR RE-PACKAGED. A PICTURE OF THE FAILURE WAS UPLOADED. THE PRODUCT WILL BE RETURNED. THERE WAS NO REPORTED PATIENT INJURY. (B)(4): ONE NON STERILE BOX OF 6F .070 XB 3.5 100CM, CATALOG# 67005400 AND LOT# 15684855 WAS RECEIVED FOR ANALYSIS OPENED OF CLOSURE LABEL. THE POUCH WITH THE DEVICE WAS SEALED CORRECTLY, A FOREIGN MATERIAL WAS OBSERVED ON THE POUCH NEAR TO POUCH SEAL. NO OTHER VISUAL ANOMALY WAS NOTED ON THE RECEIVED PRODUCT. THE FOREIGN MATERIAL WAS MEASURED AGAINST SPECIFICATION PER CFT 02001 REV. 4 AND THE SIZE OF IT WAS FOUND ABOVE TO THE ACCEPTANCE CRITERIA OF 0.050 MAXIMUM, THE FOREIGN MATERIAL WAS SENT TO ANALYTICAL LAB IN ORDER TO IDENTIFY THE SOURCE OF IT, THE FT-IR RESULTS INDICATE THAT THE SAMPLE IS THE SAME MATERIAL OF THE MOUNTING CARD (CELLULOSE). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED CUSTOMER COMPLAINT OF FOREIGN MATERIAL WAS CONFIRMED THROUGH FAILURE ANALYSIS AND IDENTIFIED AS THE SAME MATERIAL AS THE MOUNTING CARD. A RISK ASSESSMENT WAS INITIATED TO EVALUATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT WHITISH FOREIGN MATTER WAS FOUND INSIDE OF THE STERILE POUCH OF THE 6F .070 XB 3.5 100CM VISTA BRITE TIP GUIDING CATHETER (GC) DURING INCOMING VISUAL CHECK PROCESS AT THE WAREHOUSE. THE OUTER PRODUCT BOX AND STERILIZED POUCH WERE INTACT, AND THE SEAL OF THE POUCH WAS NOT OPENED. THE ACTUAL PRODUCT HAD NO DAMAGE. THERE WERE NO ANOMALIES EXCEPT FOR THIS FAILURE. THE PRODUCT HAD BEEN ALREADY THIS CONDITION WHEN IT WAS DELIVERED. THE PRODUCT WAS HANDLED AND STORED AS PER THE USUAL PROCEDURE. IT WAS NOT SHIPPED OUT OF THE WAREHOUSE AND WAS NOT CLINICALLY USED. THE PRODUCT WAS NEITHER RE-STERILIZED NOR RE-PACKAGED. A PICTURE OF THE FAILURE WAS UPLOADED. THE PRODUCT WILL BE RETURNED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15684855

    Patients

    Seq Age Sex Outcome Treatment
    1