BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 BLUE L

    MDR report key: 19762441 · Received July 17, 2024

    Report

    Report Number
    9610847-2024-00198
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    May 23, 2024
    Report Date
    August 14, 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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 BLUE LEAKED THE PATIENT REPLACED THE TEE FOR INFUSION THERAPY ON (B)(6) 2024, AND AT 6:34 ON MAY 23 THE PATIENT'S FAMILY NOTICED THAT THE BED UNIT WAS WET AND THE INFUSION TUBE CONNECTION WAS LEAKING, THE NURSE SEARCHED FOR THE CAUSE ALONG THE INFUSION PATHWAY AND FOUND THAT THE TEE WAS CRACKED AND LEAKING, REPLACED THE TEE, EXPLAINED IT TO THE FAMILY, CALMED THE PATIENT'S FAMILY, AND TRIED TO GAIN UNDERSTANDING. TRANSLATED WITH DEEPL.COM (FREE VERSION).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351254 BD CONNECTA PLUS3 BLUE L STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3181290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown