BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER

    MDR report key: 9118592 · Received September 25, 2019

    Report

    Report Number
    3006948883-2019-00804
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 4, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050849. 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. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYSTYRENE. A SUBSEQUENT REVIEW OF THE MANUFACTURING PROCESS WAS UNABLE TO IDENTIFY ANY POTENTIAL SOURCES FOR THIS MATERIAL THAT COULD HAVE ORIGINATED AT OUR FACILITY. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AFTER THE NURSE OPENED THE INTIMA-II PACKAGING, THERE WAS A WHITE FOREIGN MATTER ON THE WHITE CATHETER, WHICH FELL OFF AS SOON AS SHE TOUCHED IT, IT LOOKED LIKE PLASTIC. AT PRESENT, THE FOREIGN MATTER HAS BEEN REMOVED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AFTER THE NURSE OPENED THE INTIMA-II PACKAGING, THERE WAS A WHITE FOREIGN MATTER ON THE WHITE CATHETER, WHICH FELL OFF AS SOON AS SHE TOUCHED IT, IT LOOKED LIKE PLASTIC. AT PRESENT, THE FOREIGN MATTER HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915480 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050849

    Patients

    Seq Age Sex Outcome Treatment
    1 Other