BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM W/EXTENSION SET

    MDR report key: 7427233 · Received April 12, 2018

    Report

    Report Number
    9610847-2018-00097
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    March 21, 2018
    Report Date
    May 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
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: 7241814. D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2022. H.4. DEVICE MANUFACTURE DATE: 12/11/2017. H.6. INVESTIGATION SUMMARY: LOT ANALYSIS: ALL LOTS: PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET UP AND IN PROCESS SAMPLES (INCLUDING BUT NOT LIMITED) FOR LEAKAGE, SLIT QUALITY AND BOND/WELD STRENGTH WERE PERFORMED THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. VISUAL ANALYSIS OBSERVATIONS AND TESTING: A TOTAL OF 9 Q-SYTE UNITS CONNECTED TO EXTENSION SETS WERE RECEIVED AS FOLLOWS: 7178885: 7 UNITS RECEIVE IN SEALED PACKAGES 1 RECEIVED ON AN OPEN PACKAGE. 7241814: 1 UNIT RECEIVED ALONG WITH A VACUTAINER BLOOD COLLECTION AND AN OPEN-EMPTY PACKAGE. VISUAL/MICROSCOPIC EVALUATION: 7178885: ALL UNITS NO DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE Q-SYTE UNITS OR THE EXTENSION SETS. WATER LEAK TEST (MM-110): ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE EXTENSION SETS WITH THE Q-SYTE CONNECTED TO IT, NO LEAKAGE WAS OBSERVED ON NEITHER THE ACTUATED NOR THE UN-ACTUATED POSITION ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE Q-SYTE UNIT, NO LEAKAGE WAS OBSERVED ON NEITHER THE ACTUATED NOR THE UN-ACTUATED POSITIONS. 7241814: DAMAGE WAS OBSERVED ON THE SEPTUM TOP DISK-SLIT NO DAMAGE WAS OBSERVED ON THE COLUMN WALL DAMAGE (TEAR) WAS OBSERVED ON THE SLIT OF THE SEPTUM BOTTOM DISK (UNIT WAS DISASSEMBLED AFTER WATER/LEAK TEST) WATER LEAK TEST (MM-110): ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE EXTENSION SET WITH THE Q-SYTE CONNECTED TO IT, NO LEAKAGE WAS OBSERVED ON NEITHER THE ACTUATED NOR THE UN-ACTUATED POSITION. ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE Q-SYTE UNIT, NO LEAKAGE WAS OBSERVED ON NEITHER THE ACTUATED NOR THE UN-ACTUATED POSITIONS. INVESTIGATION CONCLUSION: NO LEAKAGE WAS OBSERVED IN THE ACTUATED NOR THE UN-ACTUATED POSITIONS. THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE WAS FOUND ON A BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM W/EXTENSION SET AFTER PERFORMING BLOOD SAMPLING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267509 BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM W/EXTENSION SET INTRAVASCULAR CATHETER ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7241814 30382903851028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other