BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 6077550 · Received November 3, 2016

    Report

    Report Number
    8041187-2016-00077
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 18, 2016
    Report Date
    January 11, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). DEVICE EVALUATION: 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 5141428. NO ABNORMALITIES WERE OBSERVED AFTER REVIEWING PREVENTIVE MAINTENANCE, CALIBRATION, AND EQUIPMENT. CONCLUSIONS - BD WAS UNABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. IF A SAMPLE IS RETURNED AFTER THIS TIME, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - THE CUSTOMER PROVIDED 6 PHOTOS FOR EVALUATION. THE PHOTOS SHOWED ABOUT 1/3 OF THE TUBING OF THE CATHETER BROKEN OFF FROM THE CATHETER. CONCLUSION - BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. A POTENTIAL ROOT CAUSE IS THE CATHETER WAS CUT BY A SHARP OBJECT. THE MANUFACTURING PROCESS WAS REVIEWED AND THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES COULD HAVE CAUSED THIS NONCONFORMANCE. IF THE DEFECT OCCURRED IN THE MANUFACTURING FACILITY, THE NONCONFORMANCE WOULD HAVE RESULTED FROM A LIE DISTANCE FAILURE. THERE IS 100% IN-LINE LIE DISTANCE INSPECTION SYSTEM TO DETECT AND REJECT CATHETER SPEAR THROUGH AND LIE DISTANCE FAILURE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS A SAMPLE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA OF THE SUSPECT DEVICE BROKE WHILE INSIDE THE PATIENT VEIN. AN EXPERIENCED NURSE INSERTED THE DEVICE, NOTING THE INSERTION WAS SIMPLE AND "CLEAN" AND DID NOT REQUIRING MANEUVERING IN THE VEIN. SHE COLLECTED BLOOD AND THEN TRIED TO FLUSH THE DEVICE WITH NACL 0.9% BUT FELT RESISTANCE AND NOTED THE SITE STARTED TO SWELL. NO MORE THAN 2ML OF NACL HAD BEEN FLUSHED INTO THE SITE. SHE IMMEDIATELY REMOVED THE DEVICE AND IT WAS FOUND BROKEN. THE PATIENT HAD AN ULTRASOUND AND X-RAY OF THE LEFT HAND AND WRIST WHICH CONFIRMED THE PRESENCE OF A FOREIGN BODY OF APPROXIMATELY 1.1MM. THE PATIENT HAD SURGERY TO REMOVE THE BROKEN CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729152 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER SAFETY PORTED CATHETERS FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 5141428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention