BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 BLUE

    MDR report key: 19824509 · Received July 25, 2024

    Report

    Report Number
    9610847-2024-00209
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    May 17, 2024
    Report Date
    April 30, 2025
    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

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394602 AND LOT NUMBER 3181290. 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.

    Additional Manufacturer Narrative · 0

    LOT NUMBER UPDATED TO UNKNOWN. INITIAL LOT WAS IN ERROR. INVESTIGATION HAS BEEN UPDATED ACCORDINGLY. THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY (CHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A DEVICE HISTORY RECORD(DHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A REVIEW OF THE APPLICABLE RISK DOCUMENTATION INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 BLUE LEAKED. ON (B)(6) 2024, THE PATIENT CHANGED THE TEE FOR INFUSION THERAPY, AND AT 1:10 ON MAY 17, THE PATIENT'S FAMILY FOUND THAT THE BED UNIT WAS WET, AND THE NURSE SEARCHED FOR THE CAUSE ALONG THE INFUSION PATH, FOUND THAT THE TEE CRACKED AND LEAKED, EXPLAINED TO THE FAMILY, COMFORTED THE PATIENT'S FAMILY, AND TRIED TO OBTAIN UNDERSTANDING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    LOT NUMBER UPDATED TO UNKNOWN. INITIAL LOT WAS IN ERROR. INVESTIGATION HAS BEEN UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353276 BD CONNECTA PLUS3 BLUE STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown