BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ARTERIAL CANNULA 20G/45 MM

    MDR report key: 5252039 · Received November 25, 2015

    Report

    Report Number
    8041187-2015-00016
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    November 10, 2015
    Report Date
    January 8, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K850349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF EVENT IS UNKNOWN THEREFORE THE DATE RECEIVED BY THE MANUFACTURER WAS USED. RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5142038. CONCLUSIONS - AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS VISUALLY INSPECTED AND THE BROKEN CATHETER WAS OBSERVED ON THE RETURNED SAMPLE. A CUT WAS OBSERVED ON THE EDGE OF THE BROKEN CATHETER. THE BROKEN CATHETER COULD POTENTIALLY HAVE BEEN CUT BY A SHARP OBJECT. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES WHICH COULD HAVE CAUSED THIS NONCONFORMANCE. MOREOVER, THE MANUFACTURING PROCESS HAS AN AUTOMATED VISION INSPECTION MACHINE THAT REJECTS PARTS NOT MEETING LIE DISTANCE REQUIREMENT. IF THE BROKEN CATHETER OCCURRED IN THE PROCESS, IT WOULD BE REJECTED BY THE AUTOMATED VISION INSPECTION MACHINE AS THERE IS NO LIE DISTANCE. HENCE, THIS REPORTED NONCONFORMANCE COULD HAVE OCCURRED OUT OF MANUFACTURING FACILITIES. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. SEE MANUFACTURER NARRATIVE FOR DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF THE BD ARTERIAL CANNULA, THE CANNULA BROKE AND 3 CM REMAINED IN THE ARTERY. AN ULTRASOUND WAS DONE TO CONFIRM THE INCIDENT BUT NO FURTHER INTERVENTIONS WERE PERFORMED AS IT IS THE "POLICY OF THE PHYSICIAN TO WAIT AND SEE WHAT HAPPENS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781519 BD ARTERIAL CANNULA 20G/45 MM ARTERIAL CANNULA FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 5142038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention