BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ PRN Y ADAPTER 22 GA 1 IN

    MDR report key: 17873692 · Received October 4, 2023

    Report

    Report Number
    3014704491-2023-00625
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 20, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    06943174101705
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II¿ PRN Y ADAPTER 22 GA 1 IN THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: A NEW PEN NEEDLE OF 5MM WAS CLOG.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II¿ PRN Y ADAPTER 22 GA 1 IN THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: A NEW PEN NEEDLE OF 5MM WAS CLOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343696 BD INTIMA-II¿ PRN Y ADAPTER 22 GA 1 IN INTRAVASCUALR CATHETER FOZ BD (SUZHOU) 1282505 06943174101705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown