BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 WHITE PEGS

    MDR report key: 20170867 · Received September 9, 2024

    Report

    Report Number
    9610847-2024-00253
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    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

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394601 AND LOT NUMBER 3093260. 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. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 WHITE PEGS LEAKED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HEADACHE AND WAS SCREENED FOR PATENT FORAMEN OVALE BY "FOAMING TEST". ON (B)(6) 2024, THE PATIENT WAS EXAMINED, AND A TEE TUBE WAS USED DURING THE OPERATION, AND DURING THE INFUSION OF "ACTIVATED SALINE" FOR THE PATIENT, IT WAS FOUND THAT THE TEE TUBE WAS LEAKING AND SEEPING, AND THE CONNECTION BETWEEN THE SCREW SYRINGE AND THE TEE TUBE WAS NOT LOOSENED. REPLACE THE TEE TO COMPLETE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562661 BD CONNECTA PLUS3 WHITE PEGS INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3093260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown