BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ PRN Y ADAPTER

    MDR report key: 15947851 · Received December 9, 2022

    Report

    Report Number
    3014704491-2022-00646
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 11, 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

    H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2082668. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ PRN Y ADAPTER EXPERIENCED FOREIGN MATTER WITHIN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INTRAVENOUS INFUSION, THE CLOSED VENOUS INDWELLING NEEDLE WAS PREPARED TO BE USED. WHEN CHECKING THE PACKAGE, IT WAS FOUND THAT THERE WAS A FOREIGN OBJECT IN THE INTERNAL VACUUM, AND THE INDWELLING NEEDLE WAS REPLACED WITHOUT CAUSING ANY HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ PRN Y ADAPTER EXPERIENCED FOREIGN MATTER WITHIN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INTRAVENOUS INFUSION, THE CLOSED VENOUS INDWELLING NEEDLE WAS PREPARED TO BE USED. WHEN CHECKING THE PACKAGE, IT WAS FOUND THAT THERE WAS A FOREIGN OBJECT IN THE INTERNAL VACUUM, AND THE INDWELLING NEEDLE WAS REPLACED WITHOUT CAUSING ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2915438 BD INTIMA-II¿ PRN Y ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2082668

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown