BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER

    MDR report key: 6851991 · Received September 8, 2017

    Report

    Report Number
    8041187-2017-00093
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 18, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    INVESTIGATION: RECEIVED 3 SAMPLE PHOTO'S. NO ACTUAL DEVICE WAS RETURNED. THE NONCONFORMANCE CANNOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT WILL BE REOPENED IF THE SAMPLE IS RETURNED FOR INVESTIGATION. PHOTO SHOWED REPORTED DEFECT - YES. DHR REVIEW: DEVICE HISTORY RECORD OF THE FOLLOWING PACKAGED NEEDLE (PN) AND ITS ASSEMBLED NEEDLE (AN) WERE REVIEWED. PN BATCH NO: 7080431 OF CATALOGUE NO: 381323. AN BATCH NO: 7080089 AND 7080088 OF PART NO: 8083541. NO QUALITY NOTIFICATION FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THE BATCH WAS RAISED. MANUFACTURING REVIEW: THE PREVENTIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HISTORY RECORDS WERE REVIEWED. NO ABNORMALITY WAS OBSERVED ON THE RECORDS. CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED AS NO SAMPLES WERE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING THE IV, THE CATHETER OF THE 22 G X 1.00 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER, REMAINED IN THE PATIENT. THERE WAS NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633591 22 G X 1.00 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7080431

    Patients

    Seq Age Sex Outcome Treatment
    1 Other