BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 16149398 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-106653
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    February 6, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER CONCERN: NOTICED INSULIN COMING OUT FROM THE BLUE TRANSFER GUARD CONNECTED T THE VIAL. THIS OCCURRED WHILE THE RES AND VIAL WERE STILL CONNECTED TO THE TRANSFER GUARD AND CUSTOMER WAS IN THE PROCESS OF FILLING THE RES WITH INSULIN. TRANSFER GUARD LEAK WHILE FILLING. EVALUATED 1 OPEN/USED RESERVOIR (NO CLEAR LIQUID INSIDE) AND TRANSFER GUARD NOT RETURNED. USING A NEW LAB TRANSFER GUARD, PERFORMED PRE-FILL TEST APPENDIX C. FOUND NO LEAKS DURING ANALYSIS. ALSO PERFORMED A VISUAL INSPECTION USING APPENDIX E; CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WAS FOUND; PER (B)(4). CONCLUSION: RESERVOIR PASSED PER INSPECTION NO LEAKAGE ANOMALY WAS FOUND DURING TEST (USING A NEW LAB TRANSFER GUARD). 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 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
    1536093 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG5H659 000020763000273358

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Unknown