BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 17600049 · Received August 22, 2023

    Report

    Report Number
    9610847-2023-00238
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 19, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K974083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 28-AUG-2023. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE THREE-WAY TAP WAS NOTICED TO BE DEFECTIVE AND LEAKED AT THE SEAM. TO AID IN THE INVESTIGATION, ONE SAMPLE, TWO PHOTOS AND A VIDEO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE COMPONENT WAS FOUND DAMAGED. THE TUBE THAT CONNECTS WITH THE HOUSING COMPONENT HAS A CUT THAT WAS CAUSING THE LEAK. NO DEFECT WAS FOUND IN THE TWO PHOTOS RECEIVED. THE DEFECT WAS CONFIRMED IN THE VIDEO PROVIDED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 394995, LOT 3032680. 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), CAPAS OR ABNORMAL CONDITIONS NOTED AT THE TIME OF PRODUCTION. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. MAINTENANCE RECORDS WERE EVALUATED, AND NO PROBLEMS WERE FOUND. A NOTIFICATION WAS GIVEN TO THE PERSONNEL ABOUT CORRECTLY PERFORMING THE CHALLENGES TO AVOID THESE PROBLEMS DURING NORMAL PRODUCTION. BASED ON THE INVESTIGATION, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED THAT 2 OF THE BD CONNECTA¿ STOPCOCKS WERE LEAKING. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: IV FLUID WAS MOMENTARILY CONNECTED TO A PATIENT BEFORE THE THREE WAY TAP WAS NOTICED TO BE DEFECTIVE. MEDICATION WAS SPRAYING OUT THE SIDE OF THE DEVICE. WHEN INJECTED THE TAP LEAKED AT THE SEAM PROXIMAL TO THE 3 WAY TAP. POTENTIALLY ALL INTRAVENOUS ANESTHETIC WOULD NOT BE GETTING TO THE PATIENT. THIS WAS VIDEOED. ANESTHETIST VERY CONCERNED. APPARENTLY THIS HAS HAPPENED TWICE BEFORE.

    Description of Event or Problem · 0

    IT WAS REPOTED THAT 2 OF THE BD CONNECTA¿ STOPCOCKS WERE LEAKING. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: IV FLUID WAS MOMENTARILY CONNECTED TO A PATIENT BEFORE THE THREE WAY TAP WAS NOTICED TO BE DEFECTIVE. MEDICATION WAS SPRAYING OUT THE SIDE OF THE DEVICE. WHEN INJECTED THE TAP LEAKED AT THE SEAM PROXIMAL TO THE 3 WAY TAP. POTENTIALLY ALL INTRAVENOUS ANESTHETIC WOULD NOT BE GETTING TO THE PATIENT. THIS WAS VIDEOED. ANESTHETIST VERY CONCERNED. APPARENTLY THIS HAS HAPPENED TWICE BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035659 BD CONNECTA¿ STOPCOCK INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3032680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown