BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 7232628 · Received January 31, 2018

    Report

    Report Number
    8041187-2018-00003
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 9, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHOTO INVESTIGATION ¿ NO COMPLAINT SAMPLE WAS RECEIVED FOR EVALUATION. HOWEVER, TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWED THE TOP WEB OF THE UNIT PACKAGE AND OTHER PHOTO SHOWED THE CANNULA HUB WITH BROKEN CATHETER. BASED ON THE RETURNED PHOTOS, THE REPORTED DEFECT OF BROKEN CATHETER WAS SHOWN. A DHR ON LOT 7110403 WAS PERFORMED AND NO ABNORMALITIES WERE OBSERVED AFTER REVIEWING PREVENTATIVE MAINTENANCE, CALIBRATION AND EQUIPMENT. THE MANUFACTURER PROCESS INCLUDES AN AUTOMATED VISION INSPECTION MACHINE THAT WILL REJECT PARTS NOT MEETING LIE DISTANCE REQUIREMENT. A BROKEN CATHETER WILL AUTOMATICALLY BE REJECTED AS THE LIE DISTANCE WILL BE OUT OF SPECIFICATION. THEREFORE, THE NON-CONFORMANCE COULD NOT BE DETERMINED. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE NOTICED THERE WAS NO BLOOD RETURN AFTER INSERTING A BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER. WHEN TRYING TO REMOVE THE CATHETER, THE CATHETER BROKE INTO PIECES. A PHYSICIAN MADE A SMALL INCISION TO REMOVE THE BROKEN CATHETER FROM THE PATIENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76113 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7110403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention