BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM

    MDR report key: 8551179 · Received April 25, 2019

    Report

    Report Number
    9610847-2019-00330
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 9, 2019
    Report Date
    June 5, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED A Q-SYTE UNIT FROM LOT 8178559 FOR EVALUATION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED A TEAR ALONG THE SLIT AND TOP DISK. THERE WAS NO DAMAGE TO THE COLUMN WALL OR BOTTOM DISK. BASED OFF OF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT OF DAMAGED SEPTUM. HOWEVER, SINCE THE UNIT WAS NOT RETURNED IN ITS ORIGINAL PACKAGING THE ENGINEER WAS UNABLE TO DETERMINE THE PROBABLE ROOT CAUSE FOR THIS DEFECT. DHR PERFORMED: 8137786: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 24MAY18 THROUGH 26MAY18. A POTENTIALLY RELATED (B)(4) SEPTUM DAMAGED) WAS INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER CONTROL PLAN. 8142519: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 29MAY18 THROUGH 31MAY18. A POTENTIALLY RELATED (B)(4) BOND STRENGTH OOS) WAS INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER CONTROL PLAN. 8152559: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 4JUN18 THROUGH 6JUN18. NO QUALITY NOTIFICATION WERE INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM EXPERIENCED PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTOR WAS NOTICED LEAKED ON THE 3RD DAY OF PLACEMENT ON PICC TUBING. THE SEPTUM WAS FOUND DAMAGED AFTER THE CONNECTOR WAS REMOVED.

    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 EXPERIENCED PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTOR WAS NOTICED LEAKED ON THE 3RD DAY OF PLACEMENT ON PICC TUBING. THE SEPTUM WAS FOUND DAMAGED AFTER THE CONNECTOR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343441 BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8178559 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other