BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 17141281 · Received June 16, 2023

    Report

    Report Number
    2032227-2023-218883
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 15, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    UDI-DI
    002076300027335801
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EVALUATED 1 OPEN/USED RESERVOIR (STOPPER-PLUNGER AND SET OF O-RINGS DETACHED FROM RESERVOIR) TRANSFER GUARD AND PLUNGER NOT RETURNED. PRE-FILL TEST PERFORMED; STOPPER-PLUNGER AND SET OF O-RINGS REATTACHED TO THE RESERVOIR, USING A NEW LAB TRANSFER GUARD AND PLUNGER, APPENDIX C. FOUND NO LEAKS DURING ANALYSIS. ALSO PERFORMED A VISUAL INSPECTION USING APPENDIX D; CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WAS FOUND; PER DOP114-811DOC. CONCLUSION: RESERVOIR PASSED PER INSPECTION NO LEAKAGE ANOMALY WAS FOUND DURING TEST. EVALUATED 1 OPEN/USED RESERVOIR (2.0 ML OF CLEAR LIQUID INSIDE) TRANSFER GUARD AND PLUNGER NOT RETURNED. PERFORMED PRE-FILL TEST USING A NEW LAB TRANSFER GUARD AND PLUNGER, APPENDIX C. FOUND NO LEAKS DURING ANALYSIS. ALSO PERFORMED A VISUAL INSPECTION USING APPENDIX D; CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WAS FOUND; PER DOP114-811DOC. CONCLUSION: RESERVOIR PASSED PER INSPECTION NO LEAKAGE ANOMALY WAS FOUND DURING TEST. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE IS LEAK ON O RING.  TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS CONFORMED THERE IS A LEAK IN O RING THE CUSTOMER WILL RETURN THE RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND IT WILL  BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228666 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG6P7AT 002076300027335801

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male