BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 16149521 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-106662
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    June 15, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    UDI-DI
    000020763000273358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ON (B)(6) 2022 CUSTOMER ALLEGED TRANSFER GUARD IS NOT PROPERLY ALIGNED AND IT CAUSES TO LEAK. EVALUATED ONE OPEN/USED RESERVOIR (0.2 ML OF CLEAR LIQUID INSIDE BARREL) AND PERFORMED VISUAL INSPECTION TO RESERVOIR'S TRANSFER GUARD AND FOUND TRANSFER GUARD¿S NEEDLE NOT CENTERED AS NOTED IN THE COMMENTS BY THE CUSTOMER THEN PERFORMED PRE-FILLING TEST AND TRANSFER GUARD FAILED PER SPECIFICATION DUE TO FOUND TRANSFER GUARD NEEDLE OCCLUDED. IN SUMMARY; THE CUSTOMER COMPLAINT OF TRANSFER GUARD¿S NEEDLE LEAKS COULD NOT BE CONFIRMED BUT TRANSFER NEEDLE FAILED PRE-FILLING TEST DUE TO OCCLUDED NEEDLE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT TRANSFER GUARD ANOMALY, LEAKS, DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634792 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG5XPSQ 000020763000273358

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown