BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM

    MDR report key: 8898065 · Received August 15, 2019

    Report

    Report Number
    9610847-2019-00514
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 28, 2019
    Report Date
    September 13, 2019
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: RECEIVED ONE UNUSED Q-SYTE UNIT IN AN OPENED PACKAGE FROM MATERIAL NUMBER 385100, LOT NUMBER 8243565. A VIDEO WAS ALSO SUBMITTED FOR REVIEW. IN THE VIDEO THE Q-SYTE UNIT WAS ATTACHED TO AN EXTENSION SET. VISUAL/MICROSCOPIC EVALUATION: NO PHYSICAL/MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE EXTERNAL AREA OF THE Q-SYTE UNIT. OBSERVED THERE WAS NO DAMAGE TO THE COLUMN WALL. FLOW RATE TEST: THE Q-SYTE FLOWED 25.8 LITERS/HOUR. THIS MEETS THE MINIMUM FLOW RATE SPECIFICATION OF 1 LITER/HOUR. THE Q-SYTE WAS NOT OCCLUDED. THE WATER FLOWED THRU THE Q-SYTE. VIDEO: IN THE VIDEO THE Q-SYTE UNIT WAS ATTACHED TO AN EXTENSION SET. THEN REMOVED FROM THE EXTENSION DISPLAY THE FLUID DRIPPING FROM THE END OF THE EXTENSION SET. THE Q-SYTE WAS REATTACHED TO THE EXTENSION SET. NO FLOW WAS OBSERVED. BASED ON THE EVALUATION OF THE VIDEO; THE DEFECT FLOW RATE SLOW/OCCLUDED WAS CONFIRMED. CONCLUSION: THE ACTUAL RETURNED UNIT: THE DEFECT WAS NOT IDENTIFIED, CONFIRMED OR REPLICATED WITH THE RETURNED UNIT. THE RETURNED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE FLOW RATE OF THE Q-SYTE WAS WITHIN SPECIFICATION. THE ROOT CAUSE WAS INDETERMINATE. VIDEO: ALTHOUGH THE VIDEO SHOWS THE FLUID DID NOT FLOW THROUGH THE Q-SYTE, THE ROOT CAUSE WAS INDETERMINATE. UNABLE TO CONFIRM WITH THE ACTUAL RETURNED UNIT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT SIX BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM HAVE BEEN FOUND CLOGGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT SOLUTION CLOGGED USED DURING PREPARE INFUSION.

    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 HAS BEEN REPORTED THAT SIX BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM HAVE BEEN FOUND CLOGGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT SOLUTION CLOGGED USED DURING PREPARE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693715 BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8243565 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other