BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13514773 · Received February 11, 2022

    Report

    Report Number
    9610847-2022-00060
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    January 31, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-22. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED FOUR PHOTOGRAPHS WHICH DISPLAYED THREE Q-SYTE DEIVCES, OF WHICH 2 ARE USED AND WITHOUT PACKAGING AND 1 UNUSED UNIT IS WITH THE DUST CAP INTACT AND WITHIN A SEALED PACKAGE. OBSERVATION OF THE PHOTOS REVEALS THAT THE TWO USED Q-SYTE ARE WITH THE TOP DISK PUSHED IN. THE PACKAGING IDENTIFIES THE PRODUCT FROM LOT NUMBER 1061166. THREE Q-SYTE UNITS WERE RECEIVED WHICH DISPLAY SIMILARITIES TO THAT SEEN IN THE PHOTOGRAPHS. THROUGH THE VISUAL EVALUATION OF THE DEVICES, UNITS 1 AND 2 ARE WITH THE TOP DISK PUSHED INTO THE TOP BODY. UNIT 1 DISPLAYED THE SEPTUM TOP DISK PUSHED INTO THE TOP BODY (POLYCARBONATE). THERE ARE MINIMAL TRACES OF RESIDUAL MATERIAL AND ADHESIVE PRESENT AT THE TOP DISK AND RIM OF TOP BODY WHICH CONFIRMS AN INADEQUATE BOND AT TIME OF MANUFACTURE. BASED ON THE EVIDENCE OF INSUFFICIENT ADHESIVE THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING PROCESS RELATED. UNIT 2 HAS A LARGE CIRCULAR TEAR AND IMPRESSION AT THE TOP DISK. THE TOP DISK HAS ONE AREA WHERE IT IS STILL ATTACHED TO THE TOP DISK AND THE REMAINDER HAS TRACES OF RESIDUAL MATERIAL AND ADHESIVE PRESENT AT THE TOP DISK AND RIM OF TOP BODY WHICH CONFIRMS AN ADEQUATE BOND AT TIME OF MANUFACTURE. A DEFINITE SOURCE THAT CONTRIBUTED TO THE SEPTUM TOP BODY TEARS AND SEPTUM PUSHED IN IS NOT ESTABLISHED. THIS TYPES OF DAMAGE ARE NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND EXTRANEOUS FORCE AND CANNOT BE DETERMINED WITH CERTAINTY. UNIT 3 DISPLAYED NO ABNORMALITIES OR DAMAGE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEPTUM WAS FOUND UNGLUED FROM 2 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "ACCORDING TO THE CUSTOMER'S REPORT, THE HCP FOUND THAT THE SEPTUM WAS SEPARATED FROM THE Q-SYTE BEFORE USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEPTUM WAS FOUND UNGLUED FROM 2 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE CUSTOMER'S REPORT, THE HCP FOUND THAT THE SEPTUM WAS SEPARATED FROM THE Q-SYTE BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112191 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 1061166 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown