BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2 UNIT RED CELL SET W/RC2H FIL

    MDR report key: 11942281 · Received June 4, 2021

    Report

    Report Number
    1219343-2021-00028
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 7, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    10812747013512
    PMA / PMN Number
    BK060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS NEED STICK INCIDENT OCCURRED WHILE OPERATOR WAS DISCONNECTING THE DONOR ONCE DONATION PROCEDURE WAS COMPLETED. 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. HAEMONETICS RECEIVED RETURNED SAMPLE FOR EVALUATION AND WAS NOT ABLE TO CONFIRM THE REPORTED DEFECT. A VISUAL EVALUATION WAS CONDUCTED AND A COSMETIC FLASH WAS IDENTIFIED ON THE LOWER END OF THE NEEDLE GUARD. THE FLASH THAT WAS IDENTIFIED ON THE END OF THE GUARD DID NOT INTERFERE WITH THE NEEDLE GUARD'S FUNCTION. THE NEEDLE GUARD FUNCTIONED AS INTENDED WHEN THE MECHANISM WAS ON. DHR REVIEW INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO APPROVED PROCEDURES AND MET ALL SPECIFICATIONS FOR RELEASE. BASED ON THE COMPLAINT SAMPLE EVALUATION IT HAS BEEN DETERMINED THAT THE PRODUCT WAS WORKING AS EXPECTED.

    Additional Manufacturer Narrative · 1

    ON MAY 17, 2021 THE SAMPLE WAS RECEIVED BY HAEMONETICS FOR EVALUATION. A VISUAL EVALUATION WAS CONDUCTED AND PLASTIC RESIDUE WAS IDENTIFIED ON THE LOWER END OF THE NEEDLE GUARD THUS NOT ALLOWING IT TO LOCK THE NEEDLE INTO PLACE. AS THE EVALUATION IS STILL ONGOING THE ROOT CAUSE HAS YET TO BE DETERMINED.

    Description of Event or Problem · 1

    ON MAY 06, 2021 HAEMONETICS WAS NOTIFIED OF A NEEDLE GUARD THAT DID NOT LOCK NEEDLE AFTER DISCONNECT RESULTING IN AN ACCIDENTAL NEEDLE STICK WHICH WAS OBSERVED POST PROCEDURE, UTILIZING A 2 UNIT RED CELL SET. THE EXPOSURE STATUS OF PATIENT AND OPERATOR IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837937 2 UNIT RED CELL SET W/RC2H FIL 2 UNIT RED CELL SET W/RC2H FIL GKT HAEMONETICS CORPORATION 0832F-00 0221026 10812747013512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other