BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 8152258 · Received December 11, 2018

    Report

    Report Number
    8041187-2018-00460
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903932245
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE AND NO PHOTO WAS RETURNED FOR INVESTIGATION OF THIS COMPLAINT. ONE VIDEO FILE WAS RETURNED FOR INVESTIGATION. FROM THE VIDEO, IT WAS OBSERVED THAT THE FLUID WAS LEAKING FROM THE CATHETER. HOWEVER, IT IS UNCLEAR WHERE THE LEAK IS COMING FROM. THERE IS NO SIMILAR COMPLAINT WAS RAISED FOR BATCH # 8173500 (CATALOG: 393224) DHR REVIEW SHOWED NO QN WAS RAISED FOR BATCH #8173500 (CATALOG: 393224). THERE IS NO RELATED QN ON SIMILAR DEFECT OR CONDITION FOR THE PAST 12 MONTHS. THEREFORE THE NONCONFORMANCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS WERE LEAKED DURING USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS WERE LEAKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989237 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8173500 00382903932245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other