BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM

    MDR report key: 6431582 · Received March 24, 2017

    Report

    Report Number
    8041187-2017-00033
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    December 1, 2016
    Report Date
    April 25, 2017
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED A BROKEN CATHETER THAT APPEARED TO HAVE BEEN CUT BY A SHARP OBJECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6230127. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: ALTHOUGH THE RETURNED SAMPLE CONFIRMED A BROKEN CATHETER, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT THERE IS NO PROCESS IN THE MANUFACTURING FACILITY THAT COULD HAVE CAUSED THIS TYPE OF DEFECT AND STATES THAT THE DEFECT MOST LIKELY OCCURRED OUTSIDE OF THE MANUFACTURING SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45 MM BROKE OFF IN A PATIENT'S RIGHT RADIAL ARTERY AS IT WAS BEING REMOVED. THE PATIENT RECEIVED A DUPLEX SCAN AND THE BROKEN CATHETER WAS REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214126 BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM ARTERIAL CANNULA FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6230127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention