BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVACUATED CONTAINER

    MDR report key: 13285102 · Received January 18, 2022

    Report

    Report Number
    1416980-2021-07899
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 12, 2021
    Report Date
    February 16, 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 #: THE DEVICE COULD HAVE BEEN FROM ONE OF THE FOLLOWING SUSPECT LOTS: G1251658 (INVALID LOT, POSSIBLY G151658), G152334, G150552, G151030 AND G149907. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H3, H4, H6 AND H10. H4: THE SUSPECTED LOT # G1251658 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: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND A GASH IN THE STOPPER WAS OBSERVED IN TWO PHOTOS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A USER ERROR. A 16-GAUGE SPIKE WAS INCLUDED IN THE SAMPLE PHOTO. EVACUATED CONTAINERS ARE INTENDED TO BE USED WITH A 21-GAUGE NEEDLE PER THE PRODUCT DIRECTIONAL INSERT. THE REPORTED LEAK DURING USE WAS DUE TO THE SPIKE, WHICH IS NOT COMPATIBLE WITH THE PRODUCT. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 1000 ML EVACUATED CONTAINER LEAKED. THE RUBBER ON THE TOP WAS NOT SEALING PROPERLY AFTER BEING SPIKED. THE RUBBER STOPPER HAD A GASH IN THE TOP RATHER THAN A PINHOLE. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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
    151195 EVACUATED CONTAINER APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CAREFUSION 16G SPIKE SET