BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 3202766 · Received July 2, 2013

    Report

    Report Number
    9616099-2013-00419
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE BRITE TIP SHEATH COULD ONLY BE INTRODUCED WITH DIFFICULTY DUE TO NOTCHES ON THE TIP. NO PATIENT CONSEQUENCES REPORTED. THE PRODUCT WAS RETURNED AND ANALYSIS WAS PERFORMED AND SHOWED THAT THE BRITE TIP WAS FOUND WITH FRAYED/ SPLIT/ TORN. THE ACCESS LOCATION WAS FEMORAL. THE PRODUCT LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. IT IS UNKNOWN IF THE ACCESS VESSEL WAS CALCIFIED OR SCARRED. THE CANNULA WAS NOT KINKED OR BENT. THE PRODUCT WAS NOT USED PREVIOUSLY IN THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ONE NON-STERILE SI BRITE TIP 8F 35CM STR WAS RECEIVED FOR ANALYSIS IN A PLASTIC BAG. THE TIP OF THE CSI CANNULA RECEIVED WAS INSPECTED UNDER VISION SYSTEM AND FOUND TO HAVE FRAYED/ SPLIT/ TORN DAMAGES. IN ADDITION, THE CANNULA WAS RECEIVED KINKED AT 20.0 CM AND AT 33.0 CM FROM DISTAL END. THE SI BRITE TIP 8F 35CM STR CANNULA OD AND ID WERE MEASURED NEAR THE KINKED AREAS, AND RESULTS WERE FOUND WITHIN SPECIFICATION. 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 COMPLAINT REPORTED BY THE CUSTOMER ¿ENDOVASCULAR VASCULAR ACCESS-CATHETER SHEATH INTRODUCER (CSI)- INSERTION DIFFICULTY¿ COULD NOT BE CONFIRMED DURING THE ANALYSIS DUE TO THE NATURE OF THIS COMPLAINT (INSERTION DIFFICULTY IN THE ARTERY). HOWEVER, THE PRODUCT MALFUNCTION CODE COMPLAINT REPORTED BY THE CUSTOMER ¿ENDOVASCULAR VASCULAR ACCESS-BRITE TIP/DISTAL TIP-DAMAGED-IN PATIENT¿ WAS CONFIRMED DUE TO FRAYED/ SPLIT/ TORN DAMAGES FOUND ON TIP OF RETURNED CSI CANNULA. THE EXACT CAUSE OF THE FRAYED/SPLIT/TORN CONDITION ON THE DISTAL TIP AND KINKS FOUND ON THE CSI CANNULA COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. PROCEDURAL FACTORS (INSERTION DIFFICULTY) MAY HAVE CONTRIBUTED TO THE DAMAGES FOUND AT THE CSI CANNULA DISTAL TIP. PRODUCT ANALYSIS AND DHR REVIEW RESULTS DO NOT SUGGEST THAT THESE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS. AS ADDITIONAL INVESTIGATION, THE CSI CATHETERS MANUFACTURING PROCESS WAS REVIEWED AND THERE WERE NO TOOLS, EQUIPMENT OR PRODUCT HANDLING THAT COULD CAUSE FRAYED/SPLIT/TORN, KINKS OR ANY OTHER TYPE OF DAMAGES TO THE CSI CANNULA. CONTROLS ARE IN PLACE TO VERIFY THE CSI CATHETERS FOR ANY DAMAGE AT THE CANNULA TIP. THE PRODUCED CATHETERS ARE INSPECTED 100 % BEFORE LEAVING THE FACILITY. SINCE THERE IS NO EVIDENCE THAT THIS WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE, NO CORRECTION ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE BRITE TIP SHEATH COULD ONLY BE INTRODUCED WITH DIFFICULTY DUE TO NOTCHES ON THE TIP. NO PATIENT CONSEQUENCES REPORTED. THE PRODUCT WAS RETURNED AND ANALYSIS WAS PERFORMED AND SHOWED THAT THE BRITE TIP WAS FOUND WITH FRAYED/ SPLIT/ TORN. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE ACCESS LOCATION WAS FEMORAL. THE PRODUCT LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. IT IS UNKNOWN IF THE ACCESS VESSEL WAS CALCIFIED OR SCARRED. THE CANNULA WAS NOT KINKED OR BENT. THE PRODUCT WAS NOT USED PREVIOUSLY IN THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301880 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15749405

    Patients

    Seq Age Sex Outcome Treatment
    1