BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8117016 · Received November 29, 2018

    Report

    Report Number
    9610847-2018-00405
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 8, 2018
    Report Date
    January 8, 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8093934. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED ON 04/19/2018, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF LEAKAGE OCCURRING IN THIS BATCH OF CONNECTA. 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. INVESTIGATION CONCLUSION: THE SAMPLE THAT WAS SUBMITTED BY THE FACILITY WAS SUBJECTED TO LEAKAGE TESTING; THE RESULTS FROM THIS EXPERIMENT WERE UNABLE TO IDENTIFY ANY LEAKS IN THE DEVICE THAT WOULD HAVE ORIGINATED UNDER PRODUCT SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF THE REVIEW. RATIONALE: BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD CONNECTA¿ STOPCOCK THERE WAS AN ISSUE WITH LEAKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.(B)(6). 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 DURING USE OF THE BD CONNECTA¿ STOPCOCK THERE WAS AN ISSUE WITH LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957566 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8093934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other