BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 16010743 · Received December 19, 2022

    Report

    Report Number
    3014704491-2022-00683
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    August 8, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BD SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2199545. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE 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 EXPERIENCED WATER LEAKAGE AT THE SCREW JOINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE SITUATION WHEN THE MEDICAL DEVICE ADVERSE EVENT OCCURS, IS WHEN THE TUBE IS FLUSHED, AND WATER LEAKAGE IS FOUND AT THE SCREW JOINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER EXPERIENCED WATER LEAKAGE AT THE SCREW JOINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE SITUATION WHEN THE MEDICAL DEVICE ADVERSE EVENT OCCURS WHEN THE TUBE IS FLUSHED, WATER LEAKAGE IS FOUND AT THE SCREW JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543626 BD¿ PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD SUZHOU 2199545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown