BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 WHITE PEGS

    MDR report key: 19472127 · Received June 5, 2024

    Report

    Report Number
    9610847-2024-00148
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 31, 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
    AR, SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 4 PHOTOS AND 4 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THERE WAS EMBEDDED BLACK SPOTS WITHIN THE WHITE MOLDED TAP. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO OUR MANUFACTURING PROCESS. THE BLACK SPORTS ARE MOST LIKELY BURNT RESIN. EMBEDDED FOREIGN MATTER MAY OCCUR DURING THE MOLDING PROCESS. BURNT EMBEDDED RESIN RESULT FROM MATERIAL BUILD UP IN THE BARREL/SCREW. AS THE MATERIAL FLOWS THROUGH THE BARREL/SCREW THE BUILDUP BREAKS FREE AND ENDS UP IN THE MOLD. MOLDS ARE BEING PURGED BETWEEN THE LOTS TO AVOID THE BUILDUP OF THE BURNT/LOOSE MATERIAL. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 WHITE PEGS HAD FOREIGN MATTER ITEMS CONTAMINATED THE NEWLY OPENED ITEM FOUND CONTAMINATED UNDER TWO LOT NUMBERS 3180404 D & 3032996 C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294662 BD CONNECTA PLUS3 WHITE PEGS STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3032996

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown