BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 10423657 · Received August 18, 2020

    Report

    Report Number
    9610847-2020-00253
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 29, 2020
    Report Date
    September 22, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/3/2020. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE Q-SYTE IN AN OPENED PACKAGE FROM LOT 9175176 AND THREE PHOTOS. THROUGH VISUAL EXAMINATION, THE SAMPLE AND PHOTOS REVEALED THE TOP DISK OF THE SEPTUM WAS PUSHED INTO THE TOP BODY CONFIRMING THE REPORTED DEFECT OF THE SEPTUM BEING PUSHED INTO THE ADAPTER. MICROSCOPIC EXAMINATION OF THE SAMPLE REVEALED NO RESIDUAL SEPTUM MATERIAL OR ADHESIVE DEPOSITS ON THE RIM OF THE TOP BODY OR TOP DISK. BASED ON THE EVIDENCE, IT IS LIKELY THAT THIS UNIT DID NOT RECEIVE A SUFFICIENT BOND AT THE TIME OF MANUFACTURE. THEREFORE THE MOST PROBABLE ROOT CAUSE IS A MANUFACTURING RELATED ISSUE. DHR FOR LOT 9149843 (Q-SYTE SUB-ASSEMBLY, MATERIAL #8001498) HAS BEEN REVIEWED. NO QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. DHR FOR LOT 9149846 (Q-SYTE SUB-ASSEMBLY, MATERIAL #8001498) HAS BEEN REVIEWED. THERE WAS ONE POTENTIALLY RELATED QN (200819636 - MISSING INSPECTION DATA SHEET-BOND STRENGTH) DURING THE BUILD OF THIS LOT. DHR FOR LOT 9149877 (Q-SYTE SUB-ASSEMBLY, MATERIAL #8001498) HAS BEEN REVIEWED. NO QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEPTUM OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND PUSHED INTO THE ADAPTER PRIOR TO USE WHILE OPENING THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "1. WHEN THE USER OPENED THE PRODUCT PACKAGE, THE SEPTUM WAS FOUND TO PUSH INTO ADAPTER."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEPTUM OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND PUSHED INTO THE ADAPTER PRIOR TO USE WHILE OPENING THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE USER OPENED THE PRODUCT PACKAGE, THE SEPTUM WAS FOUND TO PUSH INTO ADAPTER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883022 BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 9175176 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other