BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PIV

    MDR report key: 22976702 · Received September 5, 2025

    Report

    Report Number
    2243072-2025-01119
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 29, 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

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

    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 FMEA/EURA (D-EURA--SRD-RM0012 REV:18) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD - LEAKAGE. ON (B)(6) 2025, AT 9:10 A.M., WHILE ADMINISTERING INTRAVENOUS FLUIDS TO A POSTPARTUM WOMAN, THE ORIGINAL RETAINED NEEDLE WAS USED TO CONNECT THE INFUSION TUBE. LEAKAGE OF FLUID WAS OBSERVED AT THE CONNECTION POINT BETWEEN THE RETAINED NEEDLE CATHETER AND THE Y-TUBE. THE ISSUE WAS ATTRIBUTED TO THE MATERIAL OF THE RETAINED NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975611 UNKNOWN PIV INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown