BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM

    MDR report key: 7699822 · Received July 18, 2018

    Report

    Report Number
    9610847-2018-00218
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 10, 2018
    Report Date
    August 24, 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

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED A TOTAL OF 2 Q-SYTE UNITS WITHIN OPEN PACKAGES FROM LOT NUMBER 7209840. DHR REVIEW: 7191961 ¿ A TOTAL OF 180,000 UNITS WERE BUILT ON QFA LINE 2, FROM JULY 17, 2017 THRU JULY 20, 2017. 7191967 ¿ A TOTAL OF 180,000 UNITS WERE BUILT ON QFA LINE 3, FROM JULY 18, 2017 THRU JULY 20, 2017. 7191960 ¿ A TOTAL OF 180,000 UNITS WERE BUILT ON QFA LINE 2, FROM JULY 16, 2017 THRU JULY 17, 2016. REVIEW OF THE DHRS REVEALED ALL CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. NO QUALITY RELATED ISSUES WERE FOUND. VISUAL/MICROSCOPIC EXAMINATION: O UNIT 1- ¿ DAMAGE (TEAR) WAS OBSERVED ON THE SLIT OF THE SEPTUM TOP DISK ¿ NO OTHER DAMAGE WAS FOUND ON ANY OF THE REMAINDER COMPONENTS OF THE Q-SYTE ASSEMBLY O UNIT 2- ¿ DAMAGE (TEARS) WAS OBSERVED ON THE SLIT OF THE SEPTUM TOP DISK ¿ DAMAGE (TEARS) WAS OBSERVED ON THE COLUMN WALL ¿ NO DAMAGE WAS OBSERVED ON THE SEPTUM BOTTOM DISK (DISSECTED FOR EVALUATION) WATER LEAK TEST (MM-110): ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END THE Q-SYTE UNITS: ¿ UNIT 1 - NO LEAKAGE WAS OBSERVED ON EITHER THE ACTUATED OR THE UNACTUATED POSITIONS UNIT 2 ¿ NO LEAKAGE WAS OBSERVED WHEN TESTED ON THE UNACTUATED POSITION. LEAKAGE WAS OBSERVED WHEN THE UNIT WAS TESTED ON THE ACTUATED POSITION. THE SOURCE OF THE LEAKAGE WAS THE TEAR OF THE COLUMN WALL LEAKING THROUGH THE VENT HOLE. A DEFINITE SOURCE THAT CAUSED DAMAGE TO THE COLUMN TEAR (UNIT 2); WHICH COULD HAVE CONTRIBUTED TO THE LEAKAGE, COULD NOT BE ESTABLISHED. THE FAILURE MODES NORMALLY ATTRIBUTED TO THESE TYPES OF DAMAGE ARE INCORRECT USAGE OR EXCESSIVE ACTUATIONS. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM "LEAKED FROM TOP OF SEPTUM AFTER USED FOR 3 DAYS.¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 THE BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM "LEAKED FROM TOP OF SEPTUM AFTER USED FOR 3 DAYS.¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539240 BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM Q-SYTE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7209840 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other