BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA MULTIFLO 3-WAY MULTIPLE INFUSION MANIFOLD

    MDR report key: 12132433 · Received July 7, 2021

    Report

    Report Number
    9610847-2021-00307
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0213432. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED AND THEREFOR THE FAILURE WAS NOT CONFIRMED. FOR FURTHER INVESTIGATIONS IT'S RECOMMENDED THAT THE INVOLVED SAMPLE BE PROVIDED FOR EVALUATION. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES BUT ISSUES LIKE THIS ARE NOT DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. THERE WAS NOT ENOUGH DATA TO PROVIDE A CONCRETE ANSWER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD EXPERIENCED A VALVE THAT COULD NOT TURN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 9:00 ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR CERVICAL SURGERY DUE TO CERVICAL NEOPLASMS. BEFORE SURGERY, THE INFUSION TEE WAS CONNECTED DUE TO ANESTHESIA. WHEN USING THE INFUSION TEE, IT WAS FOUND THAT THE SCREW NUT OF THE INFUSION TEE WOULD NOT ROTATE AND COULD NOT BE USED, SO THE INFUSION TEE WAS IMMEDIATELY REPLACED WITHOUT CAUSING ANY OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023921 BD CONNECTA MULTIFLO 3-WAY MULTIPLE INFUSION MANIFOLD INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0213432

    Patients

    Seq Age Sex Outcome Treatment
    1