BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, LP

    MDR report key: 19142422 · Received April 19, 2024

    Report

    Report Number
    19142422
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    January 16, 2024
    Report Date
    January 29, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE COUNTING RAY-TEC X-RAYABLE SPONGES FROM A LAPAROSCOPY PACK, ONE OF THE SPONGES HAD LOOSE THREADS HANGING OFF THE EDGE. THE RAY-TEC SPONGES WERE TAKEN OUT OF CIRCULATION AND SEQUESTERED. ANOTHER SET OF RAY-TEC X-RAYABLE SPONGES WERE OPEN FOR THE CASE. (SAMPLE SENT TO THE MEDLINE. REF #DYNJ44769N - LOT #23KBW484 - EXPIRATION 8/31/2027). DURING THE PROCEDURE, A 4X8 RAY-TEC X-RAYABLE SPONGES WAS NOTED TO HAVE LOOPED, LOOSE STRINGS. THE RAY-TEC X-RAYABLE SPONGES WERE HANDED OFF THE FIELD AND SEQUESTERED. (SAMPLE SENT TO THE MEDLINE . REF DYNJ44771J - LOT 23KBK742 - EXPIRATION 10/31/2026). NOTE: WE HAVE HAD PREVIOUS ISSUES WITH THIS PRODUCT. (RECENTLY THERE WAS A THREAD FOUND AND REMOVED FROM A PATIENT DURING A CASE - NO PRODUCT INFORMATION KEPT SO NO MEDSUN REPORT COMPLETED AT THAT TIME.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694555 MEDLINE INDUSTRIES, LP LAPAROSCOPY KIT FDE MEDLINE INDUSTRIES, LP - SPT DYNJ44769N 23KBW484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown