BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8397193 · Received March 6, 2019

    Report

    Report Number
    9610847-2019-00202
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 18, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851003
    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

    INVESTIGATION: REVIEW OF THE DHR¿S REVEALED THAT ALL REQUIRED CHALLENGES SAMPLES, SET-UP AND IN-PROCESS TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE QUALITY SAMPLING PLANS. QN (B)(4). WAS INITIATED DURING THE BUILD OF THIS LOT 8110562. RECEIVED ONE USED Q-SYTE UNIT FROM CATALOG NUMBER 385100, LOT NUMBER 8115556. VISUAL/MICROSCOPIC EVALUATION: Q-SYTE TOP BODY DISPLAYED EXCESSIVE DAMAGE TO THE POLYCARBONATE (CRACKING) ON THE NECK OF THE TOP BODY. NO DAMAGE WAS OBSERVED TO THE SEPTUM. THE DEFECT SEPTUM DAMAGED/DEFECTIVE WAS NOT IDENTIFIED OR CONFIRMED WITH THE RETURNED UNIT. DID IDENTIFIED AND CONFIRMED EXCESSIVE DAMAGED TO THE POLYCARBONATE OF THE TOP BODY. CRACKED POLYCARBONATE ¿ A DEFINITE SOURCE THAT CONTRIBUTED TO THIS DAMAGE COULD NOT BE ESTABLISHED. PROLONGED CONTACT WITH CLEANING SOLUTIONS OR INCOMPATIBLE MEDICATIONS COULD CONTRIBUTE TO THIS TYPE OF DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE 6TH DAY THE PLACEMENT OF BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKAGE WAS NOTICED AND THE Q-SYTE WAS FOUND TO BE BROKEN.

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE 6TH DAY THE PLACEMENT OF BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKAGE WAS NOTICED AND THE Q-SYTE WAS FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186876 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8115556 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other