BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER 0.1ML

    MDR report key: 9914267 · Received April 1, 2020

    Report

    Report Number
    3006948883-2020-00112
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    March 12, 2020
    Report Date
    May 14, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FPA
    PMA / PMN Number
    K933467
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9231561. 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. DUE TO CURRENT PRACTICES BEING IMPLEMENTED BY CHINESE CUSTOMS, USED MEDICAL DEVICE CANNOT BE SUBMITTED TO THE MANUFACTURING FACILITY FOR FUNCTIONAL TESTING. PHOTOGRAPHS OF THE DEVICES WERE SUBMITTED IN LIEU OF THE PHYSICAL DEVICE; OUR EVALUATION OF THE PHOTOGRAPHS FOUND THE DEVICE TO BE FREE OF ANY DEFECT, DEFORMITIES, OR OTHER NON CONFORMANCES. WITHOUT THE ABILITY TO TEST THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRN ADAPTER 0.1ML EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURRED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRN ADAPTER 0.1ML EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372995 BD PRN ADAPTER 0.1ML INTERVASCULAR CATHETER FPA BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9231561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other