BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 RED

    MDR report key: 9124455 · Received September 26, 2019

    Report

    Report Number
    9610847-2019-00586
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 8243762. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, VISUAL EVALUATION OF THE SUBMITTED SAMPLES AND THE RESULTING REVIEW OF THE MANUFACTURING PROCESS DETERMINED THAT THE IDENTITY OF THE MATERIAL IS EXCESS SILICONE. SILICONE IS A MATERIAL USED TO MANUFACTURE THIS DEVICE, AND IS APPLIED TO THE CATHETER AS A LUBRICANT FOR REDUCED RESISTANCE DURING INSERTION. EXCESS APPLICATION OF THE LUBRICANT IS CURRENTLY POSSIBLE DUE TO LIMITATIONS IN THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 136 CONNECT A PLUS3 RED EXPERIENCED A DISCOLORED BLISTER PACK WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE OPERATING ROOM WAS OPENED, IT WAS FOUND TO HAVE STAINS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 136 CONNECTA PLUS3 RED EXPERIENCED A DISCOLORED BLISTER PACK WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE OPERATING ROOM WAS OPENED, IT WAS FOUND TO HAVE STAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920705 CONNECTA PLUS3 RED STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8243762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other