BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 9161882 · Received October 7, 2019

    Report

    Report Number
    9610847-2019-00606
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 20, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9122560. OUR RECORDS SHOW THAT THIS IS THE ONLY 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, OUR ENGINEERS EVALUATED THE RETURNED SAMPLES, BUT WERE UNABLE TO OBSERVE ANY NON-CONFORMANCE THAT COULD HAVE LEAD TO A LOOSENED CAP. OUR ENGINEERS WERE ABLE TO TIGHTEN AND REMOVE THE CAP WITHOUT EXCESS EFFORT. THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE PACKAGE THE CAP OF CONNECTA FALLS OFF WITH A BD CONNECTA¿ STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE PRODUCT PACKAGE CAP OF CONNECTA GETS OFF TOO EASILY. IT DROPS OFF TO FLOOR AND GETS CONTAMINATED. CUSTOMER IS REQUESTING FACTORY WOULD FIX CAP TIGHTER.

    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 WHEN OPENING THE PACKAGE THE CAP OF CONNECTA FALLS OFF WITH A BD CONNECTA¿ STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE PRODUCT PACKAGE CAP OF CONNECTA GETS OFF TOO EASILY. IT DROPS OFF TO FLOOR AND GETS CONTAMINATED. CUSTOMER IS REQUESTING FACTORY WOULD FIX CAP TIGHTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958758 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9122560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other