BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 16500558 · Received March 8, 2023

    Report

    Report Number
    3014704491-2023-00032
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 13, 2023
    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

    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

    INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2073071. 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, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. 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 RUBBER STOPPER WAS STAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PATIENT CATHETER MAINTENANCE, DURING PRE-USE PRN INSPECTION, THE PRN WAS FOUND TO BE UNOPENED BUT THE RUBBER STOPPER WAS STAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER RUBBER STOPPER WAS STAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PATIENT CATHETER MAINTENANCE, DURING PRE-USE PRN INSPECTION, THE PRN WAS FOUND TO BE UNOPENED BUT THE RUBBER STOPPER WAS STAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164005 BD¿ PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2073071

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown