BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II IV CATHETER

    MDR report key: 16496450 · Received March 7, 2023

    Report

    Report Number
    3014704491-2023-00031
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 6, 2023
    Report Date
    February 16, 2023
    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). INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140311. 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 AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, THE PATIENT UNDERWENT LEFT BREAST LUMPECTOMY UNDER LOCAL ANESTHESIA. DURING THE PREOPERATIVE REHYDRATION PROCESS WITH AN INTRAVENOUS INDWELLING NEEDLE, IT WAS FOUND THAT THE HEPARIN CAP OF THE INTRAVENOUS INDWELLING NEEDLE WAS LEAKING. IMMEDIATELY AFTER REPLACING THE NEW HEPARIN CAP, THE FLUID CAN BE REPLENISHED NORMALLY WITHOUT CAUSING ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86234 BD INTIMA-II IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0140311

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown