BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 14307456 · Received May 6, 2022

    Report

    Report Number
    9610847-2022-00171
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 26, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1210001. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. DEVICE MANUFACTURE DATE: 2021-08-09. MEDICAL DEVICE LOT #: 1210002. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. DEVICE MANUFACTURE DATE: 2021-08-05.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED A Q-SYTE WITH NO PRODUCT DOCUMENTATION TO INDICATE THE REFERENCE OR LOT NUMBER. A SYRINGE IS SEEN ATTACHED TO THE FEMALE PORT OF THE Q-SYTE. TWO BEADS OF LIQUID CAN BE SEEN FORMING ON THE Q-SYTE NEAR THE VENT HOLE AND AT THE WELD LINE. AS NO DAMAGE IS SEEN TO THE Q-SYTE NEAR THE WELD LINE IT IS LIKELY THAT THE BEAD OF FLUID SEEN AT THAT LOCATION LIKELY ORIGINATED FROM THE VENT HOLE AND FLOWED DOWN THE OUTSIDE OF THE BODY. LEAKAGE AT THE VENT HOLE COULD HAPPEN IF THERE IS A TEAR IN THE Q-SYTE SEPTUM COLUMN WALL OR BOTTOM DISK. THE REPORTED ISSUE WAS CONFIRMED. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. ALSO, AS THE DEVICE HAS BEEN OPENED AND USED, IT CANNOT BE DETERMINED WITH CERTAINTY WHETHER THE DEFECTS ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD Q-SYTE LUER ACCESS SPLIT SEPTUMS WERE DAMAGED, BUT STILL OPERABLE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6), 2022, QSYTE FOUND DURING THE INFUSION OF PATIENTS: THERE WERE 5 OF TRACHOMA IN THE DIAPHRAGM SHELL OF THE JOINT FOR A PERIOD OF TIME IN THE DEPARTMENT, RESULTING IN FLUID LEAKAGE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD Q-SYTE LUER ACCESS SPLIT SEPTUMS WERE DAMAGED, BUT STILL OPERABLE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2022, QSYTE FOUND DURING THE INFUSION OF PATIENTS: THERE WERE 5 OF TRACHOMA IN THE DIAPHRAGM SHELL OF THE JOINT FOR A PERIOD OF TIME IN THE DEPARTMENT, RESULTING IN FLUID LEAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252485 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 SEE H.10. 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown