BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7991238 · Received October 22, 2018

    Report

    Report Number
    9610847-2018-00336
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 27, 2018
    Report Date
    December 5, 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 2 Q-SYTE UNITS, ONE UNIT (USED) WAS RECEIVED WITHIN A SEALED PACKAGE AND THE OTHER INSIDE AN OPEN PACKAGE. BOTH UNITS WERE FROM LOT NUMBER 7272684. DHR REVIEW: 7258529 ¿ A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 25SEP17 THROUGH 26SEP17. 7258526 ¿ A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 23SEP17 THROUGH 24SEP17. 7258532 ¿ A TOTAL OF 216,000 UNITS WERE MANUFACTURED ON QFA LINE 4 STARTING ON 26SEP17 THROUGH 28SEP17. ALL CHALLENGE, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED ACCORDING TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. VISUAL/MICROSCOPIC EVALUATION: UNUSED UNIT: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON THE TOP DISK OF THE SEPTUM. USED UNIT: THE TOP DISK REVEALED DAMAGE (TEARS) ON THE SLIT AND ABOVE THE SLIT. THE COLUMN WALL REVEALED DAMAGE (TEAR).DAMAGE (TEAR) WAS OBSERVED ON THE SLIT OF THE SEPTUM BOTTOM DISK (DISASSEMBLED AFTER LEAK TEST). WATER LEAK TEST: THE TEST WAS PERFORMED BY CONNECTING THE Q-SYTE ASSEMBLY INTO THE LAB PROVIDED VALVE: UNUSED UNIT: NO LEAKAGE WAS OBSERVED ON EITHER THE ACTUATED OR UN-ACTUATED POSITIONS USED UNIT: NO LEAKAGE WAS OBSERVED ON THE UN-ACTUATED POSITION. LEAK OCCURRED WHEN THE UNIT WAS TESTED IN THE ACTUATED POSITION. THE SOURCE OF THE LEAK WAS THE CUT FOUND ON THE COLUMN WALL AND OUT THE VENT PLUG. 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. 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 · 0

    IT WAS REPORTED THAT SALINE LEAKED FROM THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SALINE LEAKED FROM THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830312 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7272684 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other