BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CATHETER 24G X 0.75IN (Y CONNECTOR END CAP, PRN)

    MDR report key: 17330460 · Received July 15, 2023

    Report

    Report Number
    3014704491-2023-00354
    Event Type
    Malfunction
    Date Received
    July 15, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K200891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2220791. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H.3. 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 DURING USE WITH BD INTIMA-II¿ CATHETER 24G X 0.75IN (Y CONNECTOR END CAP, PRN) "WELDING MARKS" WERE DISCOVERED ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, THE NURSE USED AN INTRAVENOUS INDWELLING NEEDLE FOR THE PATIENT'S INTRAVENOUS INFUSION. IT WAS FOUND THAT THERE WERE WELDING MARKS ON THE STEEL NEEDLE PILLOW CORE OF THE INDWELLING NEEDLE, WHICH WAS NOT SMOOTH ENOUGH AND AFFECTED ITS USE. THEREFORE, THE INDWELLING NEEDLE WAS REPLACED FOR PUNCTURE AND CAN BE USED NORMALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INTIMA-II¿ CATHETER 24G X 0.75IN (Y CONNECTOR END CAP, PRN) "WELDING MARKS" WERE DISCOVERED ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, THE NURSE USED AN INTRAVENOUS INDWELLING NEEDLE FOR THE PATIENT'S INTRAVENOUS INFUSION. IT WAS FOUND THAT THERE WERE WELDING MARKS ON THE STEEL NEEDLE PILLOW CORE OF THE INDWELLING NEEDLE, WHICH WAS NOT SMOOTH ENOUGH AND AFFECTED ITS USE. THEREFORE, THE INDWELLING NEEDLE WAS REPLACED FOR PUNCTURE AND CAN BE USED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992909 BD INTIMA-II¿ CATHETER 24G X 0.75IN (Y CONNECTOR END CAP, PRN) INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2220791

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown