BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8620510 · Received May 17, 2019

    Report

    Report Number
    9610847-2019-00382
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 28, 2019
    Report Date
    June 25, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON THE SUB ASSEMBLY LOTS: 8173707 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM 25JUN18 THROUGH 27JUN18. 8173708 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM 27JUN18 THROUGH 29JUN18. 8178683 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM 26JUN18 THROUGH 1JUL18. NO REJECT ACTIVITY ASSOCIATED WITH THE LOT NUMBERS PROVIDED WAS FOUND. RECEIVED ONE Q-SYTE ASSEMBLY WITHIN A SEALED PACKAGE FROM LOT NUMBER 8220679 ALONG WITH A MISCELLANEOUS IV CONNECTING SET. VISUAL/MICROSCOPIC EXAMINATION: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE Q-SYTE ASSEMBLY. THE WATER FLOWED FREELY INTO THE Q-SYTE UNIT AND OUT WITH NO OBSTRUCTION-RESISTANCE CONFIRMING BOTTOM SLIT PRESENCE. FLOW TEST: THE FLOW TEST PASSED PER SPECIFICATION OF 1 LITER/HOUR WITH THE RESULT OF 35.74 L/H. CONCLUSION(S): THE RETURNED REPRESENTATIVE UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, AND THE FAILURE DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE REPLICATED AT THE LABORATORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THE Q-SYTE CONNECTORS WERE OCCLUDED IN THE HEMODIALYSIS; WHILE THE BLOOD FLOWED SMOOTHLY AFTER THE CONNECTOR WAS REMOVED. THERE WERE 10 OCCURRENCES. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE NURSEHEAD REPORTED THAT THE Q-SYTE CONNECTORS WERE OCCLUDED IN THE HEMODIALYSIS; WHILE THE BLOOD FLOWED SMOOTHLY AFTER THE CONNECTOR WAS REMOVED. ONE UNUSED Q-SYTE FROM THE SAME LOT AND A UNUSED CONNECTING SET WILL BE SENT BACK FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THE Q-SYTE CONNECTORS WERE OCCLUDED IN THE HEMODIALYSIS; WHILE THE BLOOD FLOWED SMOOTHLY AFTER THE CONNECTOR WAS REMOVED. THERE WERE 10 OCCURRENCES. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE NURSEHEAD REPORTED THAT THE Q-SYTE CONNECTORS WERE OCCLUDED IN THE HEMODIALYSIS; WHILE THE BLOOD FLOWED SMOOTHLY AFTER THE CONNECTOR WAS REMOVED. ONE UNUSED Q-SYTE FROM THE SAME LOT AND A UNUSED CONNECTING SET WILL BE SENT BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411849 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR CATHETER FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8220679 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other