BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3006948883-2019-00150

    MDR report key: 8374041 · Received February 27, 2019

    Report

    Report Number
    3006948883-2019-00150
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    February 12, 2019
    Report Date
    April 3, 2019
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233349. OUR RECORDS SHOW THAT THIS IS THE THIRD INSTANCE OF THIS ISSUE 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. ADDITIONALLY, BASED ON THE SAMPLE PROVIDED OUR QUALITY ENGINEERS WERE ABLE TO OBSERVE A SMALL CRACK IN THE ADAPTER. AFTER REVIEWING THE DEVICE SUBMITTED BY YOUR FACILITY , OUR ENGINEERS DETERMINED THAT THE DIMENSIONS OF THE METAL WEDGES USED IN THIS LOT WERE APPROACHING THE UPPER LIMITS. IT IS HIGHLY POSSIBLE THAT VARIANCE IN THE WEDGE AND ADAPTER FOR THIS SPECIFIC DEVICE COULD HAVE RESULTED IN TOO TIGHT OF A FIT DURING ASSEMBLY , CAUSING THE CRACK OBSERVED IN THE ADAPTER WALL. TO ADDRESS THIS ISSUE WE HAVE CONSULTED THE SUPPLIER OF THE METAL WEDGES, INCREASE THE WINDOW FOR SWAGE DEPTH TO PROVIDE ADDITIONAL ROOM FOR AN OVERSIZED WEDGE, AND ADDED A COMPLETE CHECK OF ALL FINISHED GOODS FOR THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD A CRACK ON THE SEPTUM AND TUBING CONNECTION CAUSING LEAKAGE DURING INFUSION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD A CRACK ON THE SEPTUM AND TUBING CONNECTION CAUSING LEAKAGE DURING INFUSION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other