BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BD

    MDR report key: 19060913 · Received April 8, 2024

    Report

    Report Number
    3002601200-2024-00126
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    November 23, 2023
    Report Date
    April 30, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    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 COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED AS NO MATERIAL AND BATCH/LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD(DHR) REVIEW COULD NOT BE PERFORMED AS NO MATERIAL AND BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A RETAIN SAMPLE ANALYSIS REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A REVIEW OF THE APPLICABLE RISK DOCUMENTATION INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE, MATERIAL AND BATCH/LOT NUMBER INFORMATION. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PROVIDED LOT NUMBER 1142022 COULD NOT BE ASSOCIATED WITH ANY KNOWN INTIMA-II PRODUCT LINES IN COMPANY DATABASE. PROVIDED MATERIAL NUMBER WAS SIMILARLY NOT ASSOCIATED WITH ANY INTIMA-II PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNKNOWN BD ADAPTER/CONNECTOR WAS DEFECTIVE/DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, LEAKAGE OCCURRED DURING THE PATIENT'S INFUSION, AND THEN IT WAS DISCOVERED THAT THERE WAS A CRACK IN THE HEPARIN CAP OF THE INDWELLING NEEDLE, AND THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW CLOSED INTRAVENOUS INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427682 UNKNOWN BD INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown