BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER

    MDR report key: 6761055 · Received August 2, 2017

    Report

    Report Number
    8041187-2017-00063
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 15, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE OR PHOTO WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A DHR REVIEW WAS COMPLETED OF PACKAGED NEEDLE BATCH 6251093, CATALOGUE NUMBER 381212 AND ITS ASSEMBLED NEEDLE BATCH 6235438. PART NUMBER YF01212SGT WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RECEIVED TO CONFIRM THE STATED DEFECT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED ON A 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER THE CONSUMER NOTICED A PIECE OF LINT ON THE END OF THE INTRODUCER PRIOR TO USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540562 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6251093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other