BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ EXTENSION SET MICRO BORE

    MDR report key: 8016849 · Received October 29, 2018

    Report

    Report Number
    9610847-2018-00347
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 7, 2018
    Report Date
    December 14, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851028
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: RECEIVED ONE USED Q-SYTE EXTENSION SET IN AN OPENED PACKAGE ON 10/18/2018 FROM THE LOT NUMBER 7209862. ALSO RECEIVED A BD 2ML SYRINGE. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE/OTHER WITH LOT #7209862 REGARDING ITEM #385102. DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7212769 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM 04NOV2017 THRU 06NOV2017. REVIEW OF DHR¿S REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. 7220520 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM 10NOV2017 THRU 12NOV2017. REVIEW OF DHR¿S REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. VISUAL/MICROSCOPIC EXAMINATION: THE SEPTUM TOP DISK AND COLUMN WALL WERE SEPARATED FROM THE SEPTUM BOTTOM DISK. THERE WAS RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WAS EVIDENT ON THE RIM OF THE TOP BODY COLUMN. THE SEPTUM TOP DISK AND COLUMN WALL WERE STILL ATTACHED ON THE SLIP LUER. THE DEFECT LEAKAGE WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED UNIT. THE MISSING SEPTUM TOP DISK/COLUMN IS AN OPENED PATHWAY FOR LEAKAGE. PROBABLE ROOT CAUSE FOR THIS INCIDENT IS INDETERMINATE. 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. 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. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD Q-SYTE¿ EXTENSION SET MICRO BORE LEAKED AND BROKE AFTER REMOVAL FROM THE PATIENT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD Q-SYTE¿ EXTENSION SET MICRO BORE LEAKED AND BROKE AFTER REMOVAL FROM THE PATIENT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856430 BD Q-SYTE¿ EXTENSION SET MICRO BORE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7209862 30382903851028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other