BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE EXTENSION SETS

    MDR report key: 16018975 · Received December 20, 2022

    Report

    Report Number
    9610847-2022-00492
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    December 1, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851584
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 06-FEB-2023. H6: INVESTIGATION SUMMARY. BD RECEIVED THREE Q-SYTE ASSEMBLIES ON A TRI-EXTENSION SET FROM LOT 2033442 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER DISCONNECTED THE ASSEMBLY AND VISUALLY INSPECTED THE RETURNED UNITS. THE ENGINEER OBSERVED THAT THE DISKS ON EACH UNIT WERE NOT SLIT PROPERLY. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT. THE SEPTA ARE SLIT DURING THE MANUFACTURING PROCESS. IF A SEPTUM WAS NOT SLIT IT MAY BE A RESULT OF A BROKEN/MISSING BLADE, OR MIXED PRODUCT OF NON-SLIT SEPTUM WITH SLIT SEPTUM.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDR 1: (B)(6). 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 · 0

    IT WAS REPORTED THAT 3 BD Q-SYTE EXTENSION SETS WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QSYTE TRI EXTENSION SMALL BORE : HAVE ALL 3 SEPTUMS WITH UNABLE TO OPEN WITH NORMAL NEEDLE PUSH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD Q-SYTE EXTENSION SETS WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QSYTE TRI EXTENSION SMALL BORE : HAVE ALL 3 SEPTUMS WITH UNABLE TO OPEN WITH NORMAL NEEDLE PUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141470 BD Q-SYTE EXTENSION SETS INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2033442 00382903851584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown