BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y PRN/EC SLM

    MDR report key: 15760647 · Received November 9, 2022

    Report

    Report Number
    3014704491-2022-00555
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 13, 2022
    Report Date
    July 9, 2024
    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110886. 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. ADDITIONALLY, PHOTOGRAPHS WERE PROVIDED THAT DISPLAYED LEAKAGE OCCURRING THROUGH THE SEPTUM OF THE DEVICE. YOUR ISSUE HAS BEEN CONFIRMED. UNFORTUNATELY, THE AFFECTED 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. WITHOUT THE ABILITY TO REPLICATE THE REPORTED NON-CONFORMANCE, OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II Y PRN/EC SLM LEAKAGE OCCURRED. THIS OCCURRED 100 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: A NURSE USES A PRODUCT FOR A PATIENT AND FINDS THAT THE SEPTUM IS LEAKING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2949402 BD INTIMA-II Y PRN/EC SLM INTRAVASCUALR CATHETER FOZ BD (SUZHOU) 1356915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown