BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING

    MDR report key: 8283571 · Received January 28, 2019

    Report

    Report Number
    9610847-2019-00110
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 11, 2019
    Report Date
    April 5, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8213741 AND 7181507. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN EITHER 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 WERE ABLE TO DUPLICATE THIS EVENT THROUGH THE LEAKAGE TESTING OF THE SUBMITTED DEVICE. A SUBSEQUENT REVIEW OF OUR MANUFACTURING LINE DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS AN ABNORMALITY IN THE EQUIPMENT RESPONSIBLE FOR TUBING ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE +/- 30 INCIDENTS WERE A BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING LEAKED DURING USE. IT WAS ALSO REPORTED THAT ONE PATIENT SUFFERED A PULMONARY EMBOLISM DUE TO AIR RELATED TO THE LEAKAGE. IT IS UNKNOWN IF MEDICAL INTERVENTIONS WERE PROVIDED OR IF THERE WAS A CHANGE IN TREATMENT FOR THIS PATIENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8184942; MEDICAL DEVICE EXPIRATION DATE: 2021-06-30; DEVICE MANUFACTURE DATE: 2018-08-29; MEDICAL DEVICE LOT #: 7181507; MEDICAL DEVICE EXPIRATION DATE: 2020-05-31; DEVICE MANUFACTURE DATE: 2017-07-20. DATE OF EVENT: UNKNOWN. 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 THERE WERE +/- 30 INCIDENTS WERE A BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING LEAKED DURING USE. IT WAS ALSO REPORTED THAT ONE PATIENT SUFFERED A PULMONARY EMBOLISM DUE TO AIR RELATED TO THE LEAKAGE. IT IS UNKNOWN IF MEDICAL INTERVENTIONS WERE PROVIDED OR IF THERE WAS A CHANGE IN TREATMENT FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73417 BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other