BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 12823979 · Received November 16, 2021

    Report

    Report Number
    9610847-2021-00553
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 18, 2021
    Report Date
    March 2, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-08. D4: MEDICAL DEVICE LOT #: 1063368. D4: MEDICAL DEVICE EXPIRATION DATE: 2021-04-16. H4: DEVICE MANUFACTURE DATE: 2024-02-29. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 2 USED SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED UPON INSPECTION AND LEAKAGE TESTING OF THE SAMPLES. OF THE TWO SAMPLES ONE WAS FOUND TO HAVE LEAKAGE DURING TESTING. FURTHER OBSERVATION OF THE DEFECTIVE SAMPLE SHOWED A RAISED SURFACE ON THE A PORT. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO THE MOLDING PROCESS DURING PRODUCTION. IT WAS DETERMINED THAT THE RAISED SURFACE WAS DIRECTLY RELATED TO A SPECIFIC MOLDING STATION. PREVIOUS INVESTIGATIONS FOUND THAT OTHER DEVICES PRODUCED IN THE SAME MOLD ALSO HAD THE SAME LEAKAGE FAILURE. AS A PREVENTATIVE ACTION THE MOLD WAS DETERMINED TO BE DEFECTIVE AND WAS REPLACED TO PREVENT FURTHER REOCCURRENCE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE A VALID LOT NUMBER WAS NOT REPORTED OR COULD BE DETERMINED. THE DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED FOR THE LOT NUMBER 1063368. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NONCONFORMANCE(S).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD CONNECTA¿ STOPCOCKS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANESTHESIA DEPARTMENT HAS DETERMINED THAT WHEN USING THE 3-WAY-STOPCOK, PROPOFOL LEAKS DROP BY DROP, IT DOES NOT MATTER HOW TIGHT THE CONNECTION IS. IT HAPPENS WITH OTHER FLUIDS AS WELL, BUT BECAUSE PROPOFOL IS KIND OF MILKY IT IS ALSO MORE NOTICEABLE. MOREOVER, THE SAME ISSUE WAS EXPERIENCED TWICE WHEN TWO 3-WAY-STOPCOKS WERE CONNECTED TO EACH OTHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD CONNECTA¿ STOPCOCKS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANESTHESIA DEPARTMENT HAS DETERMINED THAT WHEN USING THE 3-WAY-STOPCOCK, PROPOFOL LEAKS DROP BY DROP, IT DOES NOT MATTER HOW TIGHT THE CONNECTION IS. IT HAPPENS WITH OTHER FLUIDS AS WELL, BUT BECAUSE PROPOFOL IS KIND OF MILKY IT IS ALSO MORE NOTICEABLE. MOREOVER, THE SAME ISSUE WAS EXPERIENCED TWICE WHEN TWO 3-WAY-STOPCOKS WERE CONNECTED TO EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717222 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1063368

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown