BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7394282 · Received April 3, 2018

    Report

    Report Number
    9610847-2018-00067
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 11, 2018
    Report Date
    April 18, 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: SUB ASSEMBLY PART #: 8001498 BD Q-SYTE ASSEMBLY AND SUB ASSEMBLY LOT #: 7143619, 7131959, 7143621 AND 7143620, DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7131959 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM MAY 29, 2017 THRU JUNE 1, 2017. 7143619 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM JUNE 9, 2017 THRU JUNE 11, 2017. 7143620 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM JUNE 1, 2017 THRU JUNE 3, 2017. 7143621 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM JUNE 3, 2017 THRU JUNE 5, 2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. MFG. IN REF TO MINIMAL RESIDUAL MATERIAL AND ADHESIVE ON TOP BODY: BOND STRENGTH IS CHECKED EVERY EIGHT HOURS (2 PARTS PER NEST) EVERY HOUR, START-UP AND AT PROCESS ADJUSTMENTS. 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. 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 FROM THE LOT NUMBER 7178869. THE SEPTUM WAS MOLDED USING THE 16-CAVITY MOLD. A SMALL PORTION OF THE SEPTUM WAS PUSHED INTO THE Q-SYTE TOP BODY. THE SEPTUM LIFTS UP ALL THE WAY AROUND FROM THE RIM OF THE TOP DISK. THE RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WAS EVIDENT ON THE RIM OF THE TOP BODY. ROOT CAUSE OF THIS INCIDENT IS INDETERMINATE. THE EVALUATION REVEALED EVIDENCE OF RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS. THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. 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.

    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 A NURSE FOUND THE SEPTUM OF A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE ¿NOT GLUED TO THE RIM¿ POTENTIALLY RISKING INJURY/LEAKAGE IF USED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234701 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE LUER ACCESS SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7178869 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other