BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 15575798 · Received October 11, 2022

    Report

    Report Number
    3014704491-2022-00476
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 15, 2022
    Report Date
    November 6, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903851102
    PMA / PMN Number
    K933467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE SAMPLE SUBMITTED BY THE FACILITY COULD NOT BE RETURNED TO THE MANUFACTURING FACILITY, DUE TO CURRENT CUSTOMS LAW IN CHINA. HIGH-RESOLUTION MICROSCOPIC IMAGES WERE TAKEN OF THE COMPONENT'S SURFACE AND SUBMITTED TO THE ENGINEERS AT THE MANUFACTURING FACILITY. USING THE IMAGES OUR ENGINEERS WERE NOT ABLE TO IDENTIFY ANY DAMAGE THAT WOULD HAVE LEAD TO A LEAK. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER E-MAIL: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER LEAKED FROM THE LUER CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE CUSTOMER'S REPORT, LEAKAGE FROM THE RUBBER COMPONENT WAS OBSERVED. NO INFORMATION ON WHAT LEAKED WAS PROVIDED IN THE INITIAL REPORT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER LEAKED FROM THE LUER CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE CUSTOMER'S REPORT, LEAKAGE FROM THE RUBBER COMPONENT WAS OBSERVED. NO INFORMATION ON WHAT LEAKED WAS PROVIDED IN THE INITIAL REPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288902 BD¿ PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) UNKNOWN 00382903851102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown