BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14407804 · Received May 16, 2022

    Report

    Report Number
    9610847-2022-00183
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 25, 2022
    Report Date
    July 5, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH, ONE WHICH DISPLAYED THE LABEL FOR A 0.16ML BD Q-SYTE FROM LOT NUMBER 1210005. THE PHOTO PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICES LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "IN THE PAST WEEK WE HAVE HAD 4 OR 5 LEAKING Q SITES. AFTER REPLACING IT, NO MORE LEAKS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICES LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "IN THE PAST WEEK WE HAVE HAD 4 OR 5 LEAKING Q SITES. AFTER REPLACING IT, NO MORE LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745020 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 1210005 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown