BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8206235 · Received December 31, 2018

    Report

    Report Number
    9610847-2018-00448
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 9, 2018
    Report Date
    January 18, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THREE BD CONNECTA¿ STOPCOCK LEAKED DURING USE ON THE SAME PATIENT. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8093647. RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED ON 04/28/20218 AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF LEAKAGE 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. INVESTIGATION CONCLUSION: BD SUBJECTED THE SAMPLES SUBMITTED BY THE FACILITY TO LEAKAGE TESTING. THE RESULTS OF THIS EXPERIMENT DETERMINED THAT THE DEVICES WERE LEAKING FROM CRACKS IN THE DEVICES' HOUSING. ROOT CAUSE DESCRIPTION: AFTER COMPLETING A REVIEW OF OUR MANUFACTURING PROCESS, THE ENGINEERS WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT. RATIONALE: BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE BD CONNECTA¿ STOPCOCK LEAKED DURING USE ON THE SAME PATIENT.

    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 THE BD CONNECTA¿ STOPCOCK LEAKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046125 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8093647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other