BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)

    MDR report key: 5667242 · Received May 19, 2016

    Report

    Report Number
    9616099-2016-00255
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 26, 2016
    Report Date
    April 28, 2016
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K922891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TRANS RADIAL NEEDLE, WHICH WAS PACKED IN A CP0428 CORPACK BROKE OFF DURING A PUNCTURE FOR A CORONARY ANGIOGRAPHY PROCEDURE (CAG). THERE WAS NO PATIENT CONSEQUENCE. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THE EVENT. THE USER WAS TRAINED. THE PRODUCT APPEARED NORMAL WHEN TAKEN FROM ITS PACKAGING. THERE WAS NO DIFFICULTY ASSEMBLING THE COMPONENTS. THE ACCESS SITE WAS A TRANSRADIAL APPROACH VIA THE RIGHT WRIST. THE ACCESS SITE WAS NOT A CHRONIC TOTAL OCCLUSION (CTO) AND IT WAS NOT INDICATED IF THERE WAS STENOSIS AT THE ACCESS SITE. THERE WAS NO MORE THAN NORMAL EXCESSIVE FORCE USED TO INSERT. THERE WAS SOME DIFFICULTY WHEN ATTEMPTING TO PUNCTURE THE SITE BECAUSE THE SKIN WAS SOMEWHAT HARDER THAN NORMAL. THERE WAS NO ACCESS SITE COMPLICATION DUE TO THE REPORTED EVENT. THREE PHOTOS WERE RECEIVED. 2 OF THE 3 PHOTOS SHOW A NEEDLE SEPARATED FROM THE HUB. THE REMAINING PHOTO IS A SNAPSHOT OF THE PRODUCT LABEL. A NON-STERILE UNIT OF THE HUB NEEDLE WAS RECEIVED INSIDE OF A PLASTIC BAG. THE HUB NEEDLE WAS RECEIVED WITHOUT THE METAL CANNULA AND IT WAS NOT RECEIVED FOR ANALYSIS. NO ANOTHER DEVICES WERE RECEIVED. PICTURES WERE RECEIVED IN THE COMPLAINT ATTACHMENT SECTION. PICTURE 1: SHOWED AN INNER LABEL FROM LOT # 17417425. PICTURE 2: SHOWED CANNULA NEEDLE AND THE HUB NEEDLE SEPARATED. PICTURE 3: SHOWED AN INNER LABEL AND CANNULA NEEDLE AND THE HUB NEEDLE SEPARATED. BLOOD RESIDUALS WERE OBSERVED ON CANNULA NEEDLE AND THE HUB NEEDLE. THE HUB WAS INSPECTED UNDER THE VISION SYSTEM AND NO CANNULA METAL RESIDUALS WERE OBSERVED INSIDE OF THE LUMEN FROM THE HUB NEEDLE. THE HUB NEEDLE MOLDING WAS OBSERVED UNEVEN. A MEETING WAS HELD WITH PET/MRB TEAM AND WAS DETERMINED THAT THIS ISSUE IS RELATED TO THE NEEDLE SUPPLIER PROCESS. SUPPLIER WAS NOTIFIED ABOUT THE NEEDLE SEPARATION AND THEY IDENTIFIED THAT A SHORT SHOT ON THE NOSE AND LUER OF THE HUB DURING THE MOLDING PROCESS. THEREFORE, THE HUB WAS NOT ENTIRELY FORMED AROUND THE CANNULA. THIS COMPLAINT WAS ESCALATED DUE TO NON-CONFORMING NEEDLE PROVIDED BY THE SUPPLIER. REVIEW OF LOT 17417425 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES. THE COMPLAINT REPORTED BY THE CUSTOMER ¿NEEDLE/ FRACTURED-SEPARATED¿ WAS CONFIRMED AS THE HUB NEEDLE WAS RECEIVED WITHOUT THE METAL CANNULA. THE CAUSE OF THE FAILURE WAS RELATED TO A SUPPLIER MANUFACTURING PROCESS. ACCORDING TO THE PRODUCT INSTRUCTION FOR USE, USERS SHOULD NOT USE THE PRODUCT IF IT IS OPENED OR DAMAGED AS WAS DONE IN THIS CASE. A RISK ASSESSMENT HAS BEEN INITIATED TO EVALUATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    FACILITY TELEPHONE NUMBER IS (B)(6). THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION (THE ENGINEERING REPORT) IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TANS RADIAL NEEDLE, WHICH WAS PACKED IN A CP0428 CORPACK BROKE OFF DURING PUNCTURE FOR A CORONARY ANGIOGRAPHY PROCEDURE (CAG) . THERE WERE NO PATIENT CONSEQUENCES. THE SALES REP WAS NOT PRESENT DURING THE EVENT. USER WAS TRAINED. TWO PHOTOGRAPHS WERE PROVIDED SHOWING THE BROKEN NEEDLE AT THE CONNECTION WITH THE HUB. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PRODUCT APPEARED NORMAL WHEN TAKEN FROM ITS PACKAGING. THERE WAS NO DIFFICULTY ASSEMBLING THE COMPONENTS. THE ACCESS SITE WAS A TRANS RADIAL APPROACH VIA THE RIGHT WRIST. THE ACCESS SITE WAS NOT A CTO AND IT WAS NOT INDICATED IF THERE WAS STENOSIS AT THE ACCESS SITE. THERE WAS NO MORE THAN NORMAL EXCESSIVE FORCE USED TO INSERT. THERE WAS SOME DIFFICULTY WHEN ATTEMPTING TO PUNCTURE THE SITE BECAUSE THE SKIN WAS SOMEWHAT HARDER THAN NORMAL. THERE WAS NO ACCESS SITE COMPLICATION DUE TO THE REPORTED EVENT. THREE PHOTOS WERE RECEIVED. THE 2 OF THE 3 PHOTOS SHOW A NEEDLE SEPARATED FROM THE HUB. THE REMAINING PHOTO IS A SNAPSHOT OF THE PRODUCT LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322037 DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS CORPORATION NA 17417425

    Patients

    Seq Age Sex Outcome Treatment
    1