BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING

    MDR report key: 17256001 · Received July 5, 2023

    Report

    Report Number
    9612164-2023-02989
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    March 23, 2021
    Report Date
    July 4, 2023
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DWE
    PMA / PMN Number
    K171979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION OF THE UNOPENED DEVICES SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. THE DEVICES WERE REMOVED FROM THE PEEL POUCHES AND WITH SOME FORCE ALL OF THE BAG SPIKES RELEASED FROM THE DEVICE. REASON FOR RETURN WAS CONFIRMED. CONCLUSION: THE REPORTED SUPPLIER BATCH IS 3000995. THIS VENDOR LOT WAS MANUFACTURED AFTER METHOD IMPROVEMENT PER SCAPA PR# 520076 (ACCORDING TO COC IT WAS MANUFACTURED ON JAN 8TH, 2021. IMPROVEMENT WAS PERFORMED BY SUPPLIER MADE SINCE LOT 3000916 ON NOV 12TH, 2020). AS PER ANALYSIS (SEE ATTACHMENT 7) IT IS CONCLUDED THAT THIS EVENT IS UNCONFIRMED FOR LOOSE PORTS SINCE THE PORT CONNECTIONS WERE DETACHED FROM THE BAG MANUALLY BY THE CUSTOMER AND WERE NOT USED IN THE PATIENT. WORK ORDER (B)(4) REPORTED FROM THIS EVENT HAVE BEEN FULLY CONSUMED ON FILED AND THERE HAVE BEEN NO REPORTED COMPLAINTS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ABNORMALITIES DURING MANUFACTURING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. COMPLAINTS RECEIVED FOR THE SAME FAILURE MODE WERE REVIEWED AND SHOWED 10 RECURRENCES ON ¿¿BAG HOLDING BARE¿¿. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS PER TREND ANALYSIS PROCEDURE. 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

    VISUAL ANALYSIS: VISUAL INSPECTION OF THE UNOPENED DEVICES SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. THE DEVICES WERE REMOVED FROM THE PEEL POUCHES AND WITH SOME FORCE ALL OF THE BAG SPIKES RELEASED FROM THE DEVICE. CONCLUSION: REASON FOR RETURN WAS CONFIRMED. UNITS WILL BE HELD IN BROOKLYN PARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990457 CUSTOM TUBING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MEDTRONIC MEXICO BB11F49R3 221502881

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown