BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 9534198 · Received December 31, 2019

    Report

    Report Number
    2243072-2019-02919
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 1, 2019
    Report Date
    January 24, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141679. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, PMA/510(K)#, AND DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO OUR DEPARTMENT OF PEDIATRICS DUE TO RESPIRATORY TRACT INFECTION. DURING THE INFUSION OF DISPOSABLE INDWELLING NEEDLE, FLUID LEAKAGE WAS FOUND AT THE INTERFACE BETWEEN INDWELLING NEEDLE AND INFUSION DEVICE D.1. MEDICAL DEVICE BRAND NAME: INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC D.1. COMMON DEVICE NAME: INTERVASCULAR CATHETER D.2. MEDICAL DEVICE MANUFACTURER: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. D.2. MEDICAL DEVICE TYPE: FOZ D.4. MEDICAL DEVICE CATALOG #: 383083 D.4. MEDICAL DEVICE LOT #: 9141679 D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-06-14 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. G.5. PMA/510(K)#: N/A. H.4. DEVICE MANUFACTURE DATE: 2019-05-21 H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INTIMA II IV CATHETER EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO OUR DEPARTMENT OF PEDIATRICS DUE TO RESPIRATORY TRACT INFECTION. DURING THE INFUSION OF DISPOSABLE INDWELLING NEEDLE, FLUID LEAKAGE WAS FOUND AT THE INTERFACE BETWEEN INDWELLING NEEDLE AND INFUSION DEVICE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO OUR DEPARTMENT OF PEDIATRICS DUE TO RESPIRATORY TRACT INFECTION. DURING THE INFUSION OF DISPOSABLE INDWELLING NEEDLE, FLUID LEAKAGE WAS FOUND AT THE INTERFACE BETWEEN INDWELLING NEEDLE AND INFUSION DEVICE

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD INTIMA II IV CATHETER EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON DECEMBER 1ST, 2019, THE PATIENT WAS ADMITTED TO OUR DEPARTMENT OF PEDIATRICS DUE TO RESPIRATORY TRACT INFECTION. DURING THE INFUSION OF DISPOSABLE INDWELLING NEEDLE, FLUID LEAKAGE WAS FOUND AT THE INTERFACE BETWEEN INDWELLING NEEDLE AND INFUSION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331599 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9141679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other