BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ 3-WAY STOPCOCK

    MDR report key: 12823737 · Received November 16, 2021

    Report

    Report Number
    9610847-2021-00550
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 18, 2021
    Report Date
    January 18, 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1063368. MEDICAL DEVICE EXPIRATION DATE: 02/29/2024. DEVICE MANUFACTURE DATE: 04/16/2021. MEDICAL DEVICE LOT #: 9255095. MEDICAL DEVICE EXPIRATION DATE: 08/31/2022. DEVICE MANUFACTURE DATE: 10/15/2019. MEDICAL DEVICE LOT #: 1084430. MEDICAL DEVICE EXPIRATION DATE: 02/29/2024. DEVICE MANUFACTURE DATE: 04/16/2021. MEDICAL DEVICE LOT #: 1061609. MEDICAL DEVICE EXPIRATION DATE: 02/29/2024. DEVICE MANUFACTURE DATE: 03/31/2021. MEDICAL DEVICE LOT #: 9270579. MEDICAL DEVICE EXPIRATION DATE: 08/31/2022. DEVICE MANUFACTURE DATE: 10/15/2019. 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: 2021-12-16 INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE 10 SAMPLES, CONSISTING OF THE REPORTED LOTS 1063368, 9255095, 1084430, 1061609 AND 9270579, SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ALL 10 SAMPLES UNDERWENT OUR INTERNAL LEAKAGE TESTING AND NONE SHOWED ANY SIGNS OF LEAKAGE. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO DEFECT WAS OBSERVED DURING LEAKAGE TESTING ON ANY OF THE SAMPLES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED 6 BD CONNECTA¿ 3-WAY STOPCOCKS HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): ¿THE ANESTHESIA DEPARTMENT HAS DETERMINED THAT WHEN USING THE [TRI-EXTENSION SET] CONNECTED THE 3-WAY-STOPCOK... PROPOFOL LEAKS DROP BY DROP, IT DOES NOT MATTER HOW TIGHT THE CONNECTION IS.¿

    Description of Event or Problem · 0

    IT WAS REPORTED 6 BD CONNECTA¿ 3-WAY STOPCOCKS HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: ¿THE ANESTHESIA DEPARTMENT HAS DETERMINED THAT WHEN USING THE [TRI-EXTENSION SET] CONNECTED THE 3-WAY-STOPCOK. PROPOFOL LEAKS DROP BY DROP, IT DOES NOT MATTER HOW TIGHT THE CONNECTION IS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720576 BD CONNECTA¿ 3-WAY STOPCOCK I.V. SET STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown