BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13588481 · Received February 23, 2022

    Report

    Report Number
    3014704491-2022-00074
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 8, 2022
    Report Date
    March 31, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. 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

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230369. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE, THE DEVICE EXPERIENCED A DAMAGED / CRACKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON (B)(6), THE NURSE PREPARED VENOUS INDWELLING FOR THE PATIENT UNDERGOING GENERAL ANESTHESIA THE NEXT DAY. AFTER SUCCESSFUL PUNCTURE WITH THE CLOSED VENOUS INDWELLING NEEDLE, THE NEEDLE WAS REMOVED AND BLEEDING WAS FOUND AT THE ROOT OF THE NEEDLE. AFTER CAREFUL EXAMINATION, THE NEEDLE WAS FOUND TO HAVE CRACKS AT THE ROOT OF THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE, THE DEVICE EXPERIENCED A DAMAGED / CRACKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON FEBRUARY 8, THE NURSE PREPARED VENOUS INDWELLING FOR THE PATIENT UNDERGOING GENERAL ANESTHESIA THE NEXT DAY. AFTER SUCCESSFUL PUNCTURE WITH THE CLOSED VENOUS INDWELLING NEEDLE, THE NEEDLE WAS REMOVED AND BLEEDING WAS FOUND AT THE ROOT OF THE NEEDLE. AFTER CAREFUL EXAMINATION, THE NEEDLE WAS FOUND TO HAVE CRACKS AT THE ROOT OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128838 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1230369

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown