BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8571323 · Received May 1, 2019

    Report

    Report Number
    9610847-2019-00348
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 11, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A Q-SYTE UNIT FROM LOT 8178559 FOR EVALUATION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THERE WAS A TEAR TO THE SLIT OF THE SEPTUM'S TOP DISK AND IT APPEARED TO BECOME UNGLUED FROM THE RIM. THERE WAS NO DAMAGE FOUND TO THE COLUMN WALL OR BOTTOM DISK. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, SINCE THE UNIT WAS RECEIVED OUTSIDE OF ITS ORIGINAL PACKAGING THE ENGINEER COULD NOT DETERMINE THE EXACT CAUSE OF THIS DEFECT. UPON FURTHER INSPECTION THE ENGINEER WAS ABLE TO DETERMINE THAT THERE WAS SUFFICIENT AMOUNTS OF ADHESIVE APPLIED TO THE TOP DISK AND SEPTUM TO CREATE A BOND DURING MANUFACTURING MEANING THAT THE SEPARATION MOST LIKELY OCCURRED AFTER MANUFACTURE. DHR WAS PERFORMED: 8137786: A TOTAL OF 182,060 UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 24MAY18 THROUGH 26MAY18. ¿ A POTENTIALLY RELATED QN (200751695-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 QN (200752700-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 DAMAGED PRODUCT OCCURRED WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON THE SECOND OF PLACEMENT, NOTICED THAT THE SEPTUM WAS UNGLUED AT RIM AFTER BEEN FLUSHED."

    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 DAMAGED PRODUCT OCCURRED WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON THE SECOND OF PLACEMENT, NOTICED THAT THE SEPTUM WAS UNGLUED AT RIM AFTER BEEN FLUSHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361294 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR CATHETER FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8178559 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other