BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ IV CATHETER

    MDR report key: 7704021 · Received July 19, 2018

    Report

    Report Number
    8041187-2018-00242
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    June 22, 2018
    Report Date
    August 17, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE NONCONFORMANCE CANNOT BE CONFIRMED AS NO ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. DHR REVIEW SHOWS THE PACKAGED NEEDLE BATCH 7020231, CATALOGUE NUMBER 388433 AND ITS ASSEMBLED NEEDLE BATCH 7020274 CATALOGUE NUMBER 8301330 HAD NO NOTIFICATIONS FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THE BATCH. THE PREVENTIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HISTORY RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. NO CAPA IS REQUIRED. THE COMPLAINT WILL BE REOPENED IF THE SAMPLE IS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ IV CATHETER THERE WAS AN ISSUE WITH TIP DEFECT. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ IV CATHETER THERE WAS AN ISSUE WITH TIP DEFECT. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ IV CATHETER THERE WAS AN ISSUE WITH TIP DEFECT. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544699 BD INSYTE¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7020231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other