BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 14731444 · Received June 17, 2022

    Report

    Report Number
    3014704491-2022-00227
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    April 3, 2022
    Report Date
    June 20, 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

    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: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM OBSERVED THAT THE UNIT PACKAGE OF THE SAMPLE HAS BEEN REMOVED, THE FIN-SHAPED PART OF THE PADDLE HUB IS BROKEN AND MISSING, AND THE BROKEN SURFACE CANNOT BE IDENTIFIED. A RETAINED SAMPLE WAS INSPECTED BY THE TEAM AND NO ABNORMALITY WAS FOUND AT THE PADDLE HUB. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. AS NO DEFECTIVE SAMPLES WERE RECEIVED, A ROOT CAUSE COULD NOT BE ESTABLISHED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD A DAMAGED HUB ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE USER FACILITY REPORTED THAT AFTER OPENING THE PACKAGE, THE FIN NEEDLE HUB OF THE CLOSED VEIN INDWELLING NEEDLE WAS BROKEN AND COULD NOT BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD A DAMAGED HUB ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER FACILITY REPORTED THAT AFTER OPENING THE PACKAGE, THE FIN NEEDLE HUB OF THE CLOSED VEIN INDWELLING NEEDLE WAS BROKEN AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397554 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1076046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown