BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8054948 · Received November 9, 2018

    Report

    Report Number
    9610847-2018-00374
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 24, 2018
    Report Date
    December 13, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED (B)(4) UNITS WITHOUT PACKAGING MATERIAL. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT CONDITION OF LEAKAGE WITH LOT NUMBER # 7327640 REGARDING ITEM # 385100. DHR REVIEW WAS PERFORMED ON THE SUB-ASSEMBLY LOTS: 7325998: A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 2 FROM 29NOV17 THROUGH 1DEC17 7325504: A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 3 FROM 1DEC17 THROUGH 3DEC17 BOTH OF THE LOTS ABOVE HAD A NON-RELATED TD (2017-89 FOR SCALES SWI) IMPLEMENTED DURING PRODUCTION. 7331828: A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 3 FROM 6DEC17 THROUGH 8DEC17 ALL CHALLENGE, SET-UP AND IN PROCESS SAMPLES AND TESTING WERE PERFORMED IN ACCORDANCE WITH QUALITY CONTROL PLAN ALL PASSED PER SPECIFICATIONS. PROBABLE ROOT CAUSE IS INDETERMINATE. UNIT 1: A DEFINITE SOURCE THAT CAUSED THE DAMAGE OBSERVED ON THE COLUMN WALL (CONTRIBUTIVE TO LEAKAGE) COULD NOT BE DETERMINED. LEAKAGE DUE TO A COLUMN TEAR IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS. UNIT 2: THE UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE FAILURE COULD NOT BE CONFIRMED OR REPRODUCED IN THE LABORATORY. Q-SYTE PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS TO ENSURE PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893904 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7327640 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other