BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 14780565 · Received June 22, 2022

    Report

    Report Number
    9610847-2022-00232
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    April 15, 2022
    Report Date
    June 3, 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

    INVESTIGATION SUMMARY: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. LOT 1140011 IS A FINAL PRODUCT LOT. Q-SYTE SUBASSEMBLIES USED IN THAT FINAL LOT WERE BUILT UNDER PART NUMBER 8001498 LOTS 1140142 AND 1140146. DHR FOR LOT 1140142 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 3 FROM 27MAY2021 THROUGH 29MAY2021 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. DHR FOR LOT 1140146 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 3 FROM 24MAY2021 THROUGH 26MAY2021 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE LUER ACCESS SPLIT SEPTUM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: ON (B)(6) 2022, AFTER PUNCTURING THE INDWELLING NEEDLE FOR THE PATIENT, THE NURSE CONNECTED THE SEPTUM JOINT, AND THEN CONNECTED THE INFUSION BOTTLE. FLUID LEAKED FROM THE JOINT, AND THE NEW SEPTUM JOINT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455058 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 1140011 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown