BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 7261228 · Received February 9, 2018

    Report

    Report Number
    8041187-2018-00014
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 16, 2018
    Report Date
    January 17, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION SUMMARY: 4 SAMPLES WERE RETURNED FOR THE INVESTIGATION OF THIS COMPLAINT. VISUAL INSPECTION, (B)(4) FITTING INSPECTION AND LUER TAPER MEASUREMENT WERE CONDUCTED ON THE RETURNED SAMPLE. THE SAMPLE PASSED THE ACCEPTANCE CRITERIA. DHR REVIEWED LOT MASTER FOR BATCH #7051464. NO QN WAS ISSUED FOR THIS VPS BATCH. ROOT CAUSE DESCRIPTION THE PROBABLE ROOT CAUSE COULD BE DUE LUBRICANT MIGRATION TO CANNULA HUB WHICH OCCUR WITH AGE. THE LUBRICATION LOWERS THE FRICTION OF INTERFERENCE FIT BETWEEN THE LUER TAPER AND SARSTEDT ADAPTOR AND HENCE RESULTED IN THE DISCONNECTION. THERE IS A CAPA (CAPA#(B)(4)) INITIATED FOR LUER DISCONNECTION. THIS BATCH WAS PRODUCE BEFORE THE CAPA ACTION IMPLEMENTATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER WAS FOUND LEAKING BLOOD AS THE ADAPTER SLIPPED OFF WHEN DRAWING BLOOD FROM THE CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102606 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7051464

    Patients

    Seq Age Sex Outcome Treatment
    1 Other