BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 7965476 · Received October 15, 2018

    Report

    Report Number
    9610847-2018-00328
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 21, 2018
    Report Date
    November 12, 2018
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8033736. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED ON 02/09/2018, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF DAMAGED TUBING 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 OF PACKAGED GOODS. VISUAL OF OBSERVATION OF THE SAMPLES SUBMITTED BY THE FACILITY AND THE REVIEW OF THE MANUFACTURING PROCESS WERE UNABLE TO PRODUCE ANY INDICATION OF A ROOT CAUSE ASSOCIATED WITH THE MANUFACTURING PROCESS. THE CONNECTA PRODUCT LINE SHOULD BE USED FOR INFUSION THERAPY ONLY AND IS NOT RATED FOR PRESSURIZED USE SUCH AS INJECTION. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. BASED ON AN EVALUATION OF LOW SEVERITY, IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK CRACKED DURING THE INJECTION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THE BD CONNECTA¿ STOPCOCK CRACKED DURING THE INJECTION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804787 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8033736

    Patients

    Seq Age Sex Outcome Treatment
    1 Other