BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 BLUE

    MDR report key: 19510936 · Received June 11, 2024

    Report

    Report Number
    9610847-2024-00162
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    April 20, 2024
    Report Date
    June 18, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394602 AND LOT NUMBER 3143759. 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. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL#394602,BATCH#3143759.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD CONNECTA PLUS3 BLUE COMPONENT DEFECTED (B)(6) 2024 PATIENT SURGERY, THE ANESTHESIOLOGIST TO ENSURE THE SMOOTH PROGRESS OF THE OPERATION, GIVE INTRAOPERATIVE DRUGS IN A TIMELY MANNER, TO THE INDWELLING NEEDLE INSTALLED TEE TUBE, INCREASE THE VENOUS ACCESS, POSTOPERATIVE ACCESS TO THE CONNECTION OF INTRAVENOUS INFUSION TUBES AND ANALGESIC PUMPS, ACCORDING TO THE MANAGEMENT OF STATIC THERAPY AFTER SURGERY, TAKE OUT THE EXCESS INTRAVENOUS INFUSION ADD-ON DEVICE, REMOVE THE TEE TUBE, TEE TUBE ONE OF THE JOINTS BROKEN IN THE CONNECTOR OF THE ANALGESIC PUMP, AFFECTING THE ANALGESIC PUMP, THE NURSE WORRIED ABOUT THE PATIENT'S PAIN AND SUFFERING, HURRIEDLY REMOVE THE BROKEN TEE CONNECTOR IN THE PAIN PUMP RECONNECTED ANALGESIC PUMP, THE NURSE WORRIED ABOUT THE PATIENT'S PAIN AND SUFFERING. THE NURSE WAS WORRIED ABOUT THE PATIENT'S PAIN, SO SHE HURRIEDLY REMOVED THE BROKEN TEE CONNECTOR FROM THE ANALGESIC PUMP AND RECONNECTED THE ANALGESIC PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295075 BD CONNECTA PLUS3 BLUE STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3143759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown