BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8237210 · Received January 10, 2019

    Report

    Report Number
    9610847-2018-00484
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 26, 2018
    Report Date
    February 19, 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: DHR REVIEW WAS PERFORMED ON THE SUB-ASSEMBLY LOTS: 8004562 - A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA # 2 FROM 10JAN18 THROUGH 12JAN18. 8004564 - A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA # 3 FROM 13JAN18 THROUGH 15JAN18. 8004568 - A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA # 3 FROM 15JAN18 THROUGH 17JAN18. ALL CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED ACCORDING TO THE QUALITY PLAN AND ALL PASSED PER SPECIFICATIONS. RECEIVED ONE USED Q-SYTE WITH NO PACKAGING MATERIAL, THE UNIT WAS BROKEN DOWN INTO 2 PORTIONS. VISUAL/MICROSCOPIC EXAMINATION: ¿TRACES OF MEDICINAL RESIDUE WERE OBSERVED THROUGHOUT THE TOP AND BOTTOM BODIES. ¿THE Q-SYTE ASSEMBLY WAS RECEIVED IN 2 PORTIONS: OTHE TOP AND BOTTOM BODIES WERE SEPARATED AT THE WELD LINE. OCRACKS, BREAKAGE AND STRESS SIGNS WERE OBSERVED ON THE BOTH THE TOP AND BOTTOM BODIES. OADEQUATE TRACES OF WELD WERE PRESENT ON THE RIM OF THE BOTTOM BODY. CONCLUSION(S): TRACES OF A WELD LINE ON THE BOTTOM BODY OF THE Q-SYTE ASSEMBLY WAS PRESENT, THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. THE STRESS MARKS OBSERVED APPEAR TO BE CAUSED BY EXTERNAL FORCES APPLIED TO THE UNIT DURING USAGE. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH BROKEN ON THE OUTER COVER DURING INJECTION OF THE PATIENT.

    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 WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH BROKEN ON THE OUTER COVER DURING INJECTION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25836 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8025547 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other