BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ PERIPHERAL VENOUS CATHETER

    MDR report key: 7215937 · Received January 24, 2018

    Report

    Report Number
    8041187-2018-00002
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    December 27, 2017
    Report Date
    March 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903812234
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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.

    Additional Manufacturer Narrative · 1

    INCORRECT AWARENESS DATE ENTERED ON INITIAL MDR. CORRECTION DATE OF 1/03/2018 HAS BEEN MADE.

    Additional Manufacturer Narrative · 1

    A SECOND LOT # WAS PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR THIS LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7220167. MEDICAL DEVICE EXPIRATION DATE: 7/31/2022. DEVICE MANUFACTURE DATE: 8/8/2017. INVESTIGATION RESULTS: 1 ACTUAL SAMPLE IN OPENED PACKAGING FROM BATCH 7220167 WAS RETURNED FOR INVESTIGATION. 19 REPRESENTATIVE SAMPLES IN CLOSED PACKAGING FROM REPORTED BATCH 7111330 WERE RETURNED FOR INVESTIGATION. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. NO ABNORMALITIES WERE OBSERVED ON ALL RETURNED SAMPLES. DEVICE HISTORY RECORD OF PACKAGED NEEDLE BATCH 7220167, CATALOGUE NUMBER 381223 AND ITS ASSEMBLED NEEDLE BATCHES 7215376 AND 7201165, PART NUMBER YF01223SGT WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. DEVICE HISTORY RECORD OF PACKAGED NEEDLE BATCH 7111330, CATALOGUE NUMBER 381223 AND ITS ASSEMBLED NEEDLE BATCHES 70180081 AND 711375 PART NUMBER YF01223SGT WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. OUR QUALITY ENGINEER INSPECTED THE RETURNED UNITS AND COULD NOT IDENTIFY ANY MANUFACTURING RELATED DEFECTS. AS A RESULT, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD INSYTE¿ PERIPHERAL VENOUS CATHETER WAS FOUND WITH BURR¿S ON THE SIDE ON THE CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58399 BD INSYTE¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7111330 30382903812234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other