BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ PRN Y ADAPTER

    MDR report key: 15670863 · Received October 25, 2022

    Report

    Report Number
    3014704491-2022-00519
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    January 20, 2022
    Report Date
    October 28, 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 1111451. 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. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ PRN Y ADAPTER EXPERIENCED THE NEEDLE PIERCING THROUGH THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: AFTER UNPACKING, IT WAS FOUND THAT THE STEEL NEEDLE PIERCED THE CASING, IT WAS DAMAGED, AND IT WAS NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ PRN Y ADAPTER EXPERIENCED THE NEEDLE PIERCING THROUGH THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: AFTER UNPACKING, IT WAS FOUND THAT THE STEEL NEEDLE PIERCED THE CASING, IT WAS DAMAGED, AND IT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556259 BD INTIMA-II¿ PRN Y ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1111451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown