BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿

    MDR report key: 7370434 · Received March 26, 2018

    Report

    Report Number
    8041187-2018-00086
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 8, 2018
    Report Date
    May 1, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE RETURNED PHOTO RECEIVED FOR INVESTIGATION. FROM THE PHOTO, OBSERVED THAT THE CATHETER WAS BROKEN UNIT AND CONFIRMED THE REPORTED OBSERVATION. A TOTAL OF 4 SAMPLES (1 ACTUAL AND 3 REPRESENTATIVE FROM EACH REFERENCED LOT #) WERE RETURNED FOR INVESTIGATION. ONE USED ACTUAL SAMPLE WITH ONLY THE BROKEN OFF PORTION OF THE CATHETER WAS RETURNED. THE BROKEN OFF PORTION OF THE CATHETER IS 3.5CM IN LENGTH. THE BROKEN OFF PORTION OF THE CATHETER WAS EXAMINED UNDER MICROSCOPE AND OBSERVED SMOOTH EDGES AT THE EDGE OF THE BROKEN OFF PORTION. HOWEVER, THE SOURCE OF THE DEFECT COULD NOT BE DETERMINED AS THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES COULD HAVE CAUSED THIS TYPE OF NONCONFORMANCE. NO DEFECTS WERE IDENTIFIED ON THE REPRESENTATIVE SAMPLES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE REPORTED BATCHES. THE MANUFACTURING PROCESS WAS REVIEWED AND THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD HAVE CAUSED THIS NONCONFORMANCE. THERE IS AN AUTOMATED VISION INSPECTION MACHINE AT THE ARTERIAL CANNULA ASSEMBLY MACHINE TO CHECK AND AUTO REJECT PARTS NOT MEETING THE LIE DISTANCE REQUIREMENT. A BROKEN CATHETER WILL AUTOMATICALLY BE REJECTED AS THE LIE DISTANCE WILL BE OUT OF SPECIFICATION. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7110139, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2017-05-24. MEDICAL DEVICE LOT #: 7199164, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-08-23. MEDICAL DEVICE LOT #: 7234345, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2017-10-04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REMOVING A BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿, IT BROKE AND REMAINED IN THE PATIENT. IT WAS ABLE TO BE REMOVED WITH TWEEZERS AND THERE WAS NO MENTION OF MEDICAL INTERVENTIONS OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215060 BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ ARTERIAL CANNULA FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other