BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PIV

    MDR report key: 20904102 · Received December 11, 2024

    Report

    Report Number
    2243072-2024-01214
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 3, 2025
    Manufacturer
    BECTON DICKINSON
    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 CHECK WAS UNABLE TO BE PERFORMED SINCE NO MATERIAL, LOT/BATCH NUMBER WAS PROVIDED. A DEVICE HISTORY REVIEW WAS UNABLE TO BE PERFORMED SINCE NO MATERIAL, LOT/BATCH NUMBER WAS PROVIDED. AR-CODE--A REVIEW OF THE APPLICABLE RISK DOCUMENTATION INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. A RETAIN SAMPLE ANALYSIS COULD NOT BE PERFORMED AS NO MATERIAL, BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    WHEN USING A DISPOSABLE INTRAVENOUS NEEDLE TO INFUSE A PATIENT, AFTER COMPLETING THE PUNCTURE AND FIXATION ACCORDING TO THE STANDARD OPERATION, THE INFUSION WAS STARTED, AND LIQUID LEAKAGE WAS FOUND AT THE LINK BETWEEN THE CONE AND THE INFUSION TUBE, SO THE INFUSION COULD ONLY BE TERMINATED, AND THE PATIENT WAS REPLACED WITH A NEW DISPOSABLE INTRAVENOUS NEEDLE FOR THE SECOND PUNCTURE AND INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437928 UNKNOWN PIV CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown