BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS

    MDR report key: 17258631 · Received July 5, 2023

    Report

    Report Number
    9612164-2023-02995
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 21, 2021
    Report Date
    July 5, 2023
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DWF
    UDI-DI
    00763000193362
    PMA / PMN Number
    K171979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS THE RED HEMOSTASIS CAP IS LOOSE ON THE DEVICE. THE RED HEMOSTASIS CAP AND THE 3/8 INCH CONNECTOR WERE MEASURED AGAINST THE SPECIFICATION. RED HEMOSTASIS CAP - CIRCLED ID WAS MEASURED USING AN OGP TO BE 0.386 INCHES, THE SPECIFICATION, 06565 HAS THE ID TO BE 0.360 TO .0390 INCHES. NOTE: THE OUTER ID WAS MEASURED TO BE 0.479 INCHES, THERE IS A LARGE TAPER CAUSING THE CAP TO BE LOOSE. THERE IS NO SPECIFICATION FOR THIS LOCATION. 3/8 INCH CONNECTOR - FIRST AND SECOND BARB OD WERE MEASURED USING AN OGP TO BE 0.452 AND 0.471 INCHES, THE SPECIFICATION, 07837 HAS THE OD'S TO BE 0.455 AND 0.479 INCHES AND ARE IDENTIFIED AS TYPICAL AND ARE NOT A CRITICAL DIMENSION. REASON FOR RETURN WAS CONFIRMED. CONCLUSION: MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THE CUSTOMER REPORTED THAT TWO BIO-MEDICUS 17FR CANNULAE WERE OPENED, BUT THE RED CAPS WERE VERY LOOSE. AFTER EVALUATION THIS COMPLAINT WAS DETERMINED TO BE A DESIGN-RELATED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED AS THIS WAS NOT RELATED TO A MANUFACTURING ISSUE. ASSESSMENT AGAINST THE MEDTRONIC RISK MANAGEMENT FILE DFMECA DOCUMENT INDICATES THAT THE CURRENT RISK ZONE DOES NOT EXCEED THE RISK ZONE PREDICTED IN THE PRODUCT DFMECA. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS INCIDENCE. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS. THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER (B)(4) AS PART OF A CAPA ACTION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THE CUSTOMER REPORTED THAT TWO BIO-MEDICUS 17FR CANNULAE WERE OPENED, BUT THE RED CAPS WERE VERY LOOSE. A THIRD CANNULA WAS OPENED AND THE RED CAP SEEMED TO ¿SEAL¿ AS USUAL. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930507 BIO-MEDICUS CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF MEDTRONIC MEXICO CB96570-017 221679568 00763000193362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown