BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD OBTURATOR FOR VENFLON¿/SAFELON¿

    MDR report key: 5341699 · Received January 4, 2016

    Report

    Report Number
    1710034-2016-00001
    Event Type
    Injury
    Date Received
    January 4, 2016
    Date of Event
    December 22, 2015
    Report Date
    January 18, 2016
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS NOT MARKETED IN THE US. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: TWO UNUSED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC ANALYSIS REVEALED THAT BOTH UNITS WERE IN ONE PIECE AND THERE WAS NO MECHANICAL/PHYSICAL DAMAGE (SPLITS OR NICKS) TO THE THREADS ROD OR CONE OF THE OBTURATOR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5133626. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT. A POTENTIAL CAUSE FOR THIS FAILURE IS THE UNITS MAY HAVE BECOME JAMMED ON THE FEEDING SYSTEM. THE MODIFICATION TO THE MA66, OBTURATOR ASSEMBLY MACHINE VACUUM PICK-UP HEAD, WAS IMPLEMENTED ON 4/2015. THE TAIL CLIPPING ISSUE WITH THE PICK-UP HEAD WAS A KNOWN POTENTIAL PROBLEM IN THE PAST AND WAS ADDRESSED WITH A MODIFICATION TO THE PICK-UP HEAD BEING THE SOLUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING A BD OBTURATOR FOR VENFLON⯓AFELON⠆ROM AN IV CATHETER, THE DEVICE BROKE OFF AND REMAINED INSIDE THE PATIENT. THE PATIENT HAD SURGERY TO TRY AND RETRIEVE THE BROKEN OBTURATOR BUT THE DEVICE WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264 BD OBTURATOR FOR VENFLON¿/SAFELON¿ OBTURATOR FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5133626

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention