BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2 UNIT RED CELL SET W/RC2H FIL

    MDR report key: 12595619 · Received October 8, 2021

    Report

    Report Number
    1219343-2021-00134
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 7, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    10812747013512
    PMA / PMN Number
    BK060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DONOR IMPACT. ALTHOUGH THERE WAS EXPOSURE TO THE NEEDLE, THE OPERATOR WAS WEARING PPE AT THE TIME OF INCIDENT. THE OPERATOR WAS SENT FOR BLOOD WORK BUT THE RESULTS ARE CONFIDENTIAL. SAMPLE WAS DISCARDED. THE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AS IT IS NOT POSSIBLE WITHOUT A PHOTO AND OR PHYSICAL SAMPLE FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A NEEDLE STICK DUE TO A NEEDLE GUARD MALFUNCTION WHICH OCCURED POST PROCEDURE TO THE OPERATOR WHEN DISCONNECTING DONOR , UTILIZING A 2 UNIT RED CELL SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497109 2 UNIT RED CELL SET W/RC2H FIL 2 UNIT RED CELL SET W/RC2H FIL GKT HAEMONETICS CORPORATION 0832F-00 0621053 10812747013512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other