BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7335034 · Received March 13, 2018

    Report

    Report Number
    9610847-2018-00065
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 27, 2018
    Report Date
    April 9, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7152691 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM JUNE 14, 2017 THRU JUNE 16, 2017. 7160880 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM JUNE 27, 2017 THRU JUNE 28, 2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. 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 FOREIGN-NON-FOREIGN WERE PERFORMED THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. 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. OBSERVATIONS AND TESTING: RECEIVED ONE UNUSED Q-SYTE UNIT IN A SEALED PACKAGE FROM LOT NUMBER 7178881. RECEIVED A BOTTLE OF E IODOPHOR DISINFECTANT. TWO PHOTOS WERE SUBMITTED FOR REVIEW. VISUAL/MICROSCOPIC EVALUATION: THERE WAS NO FM OBSERVED ANYWHERE ON THE Q-SYTE UNIT. PHOTOS SUBMITTED FOR REVIEW: PHOTO 1 DISPLAYED A Q-SYTE TOP BODY. THE EDGES WERE JAGGED AND UNEVEN. PHOTO 2 DISPLAYED A Q-TIP WITH A BLACK SUBSTANCE ON THE COTTON MATERIAL. PHOTO 3 DISPLAYED CHINESE WRITING. PHOTO 4 DISPLAYED A Q-SYTE TOP BODY. THE TOP REVEALED TWO BLACK SPECKS ON THE Q-SYTE. CONCLUSIONS: THE DEFECT FOREIGN MATTER, AS STATED AS THE REPORTED CODE WAS NOT CONFIRMED WITH THE RETURNED UNIT OR WITH THE SUBMITTED PHOTOS. WITH THE SUBMITTED PHOTOS, UNABLE TO CONFIRM OR IDENTIFIED THE FM ON THE Q-TIP AND THE TOP BODY THE RETURNED REPRESENTATIVE UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECTS THE CUSTOMER EXPERIENCED, PER THE PIR. THE DEFECTS DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED REPRESENTATIVE UNITS. THE ACTUAL UNIT DESCRIBED IN THE INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION. THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    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 AFTER USE A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND WITH ¿BLACK FOREIGN MATTER¿. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179750 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LUER ACCESS SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7178881 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other