BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y

    MDR report key: 8617793 · Received May 16, 2019

    Report

    Report Number
    8041187-2019-00383
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8235271. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF MIXED PRODUCTS OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A REVIEW OF THE MANUFACTURING DATA WAS ABLE TO DETERMINE THAT LOT #5141368 WAS PRODUCED, STERILIZED, AND SHIPPED IN JUNE OF 2015, AND LOT #8235271 WAS PRODUCED IN SEPTEMBER OF 2018. THE LARGE LAPSE IN TIME BETWEEN THE MANUFACTURE OF THESE LOTS WAS SUFFICIENT FOR OUR ENGINEERS TO DETERMINE THAT THIS ISSUE OCCURRED INDEPENDENTLY OF OUR MANUFACTURING PROCESS. PHOTO EVALUATION: THE PHOTO IS SHOWING A SHELF BOX OF CATALOG 383732 AND BATCH 5141368 PRODUCED ON JUN 2015. THE COMPLAINT IS CONFIRMED AND PRODUCT IS OUT OF SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS MIXED PRODUCT WITH A BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: EVENT DATE: (B)(6) 2019. A SHELF BOX OF SKU 383732 / LOT 5141368 IN THE CARTON OF SKU 383734 /LOT 8235271.

    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 THAT THERE WAS MIXED PRODUCT WITH A BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: EVENT DATE: (B)(6) 2019. A SHELF BOX OF SKU 383732 / LOT 5141368 IN THE CARTON OF SKU 383734 /LOT 8235271.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408012 BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8235271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other