BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVACUATED CONTAINER

    MDR report key: 13258389 · Received January 14, 2022

    Report

    Report Number
    1416980-2021-07879
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 13, 2021
    Report Date
    February 17, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    GCY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LOT #: SUSPECTED LOTS G1251658, G152334, G150552, G151030 AND G149907. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: A BATCH REVIEW WAS CONDUCTED FOR SUSPECTED LOTS G151658 (PREVIOUSLY SUBMITTED ASG1251658), G152334, G150552, G151030 AND G149907 AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H4, AND H10. H4: THE SUSPECTED LOT # G151658 WAS MANUFACTURED ON AUGUST 23, 2021. H4: THE SUSPECTED LOT # G152334 WAS MANUFACTURED ON SEPTEMBER 23, 2021. H4: THE SUSPECTED LOT # G150552 WAS MANUFACTURED ON JUNE 23, 2021. H4: THE SUSPECTED LOT # G151030 WAS MANUFACTURED ON JULY 23, 2021. H4: THE SUSPECTED LOT # G149907 WAS MANUFACTURED ON MAY 24, 2021. H10: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A1000ML EVACUATED CONTAINER WAS LEAKING. IT WAS STATED THAT THE RUBBER ON TOP AFTER BEING SPIKED WAS NOT SEALING PROPERLY. THIS WAS IDENTIFIED AFTER USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753510 EVACUATED CONTAINER APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CAREFUSION 16 GAUGE SPIKE.