BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPT, BASIC IR PACK (IRSHF)159

    MDR report key: 11276307 · Received February 3, 2021

    Report

    Report Number
    1423537-2021-00589
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 6, 2021
    Report Date
    February 11, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OIO
    UDI-DI
    10888439588224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE SAMPLE TOWELS PWTB04-STM WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT SUBMITTED ON 2/3/2021. IT WAS DETERMINED THE TOWELS WERE NOT THE SOURCE OF PARTICULATES FOUND IN THE BASIC IR PACK SANHFIRSHF. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TOWELS PWTB04-STM FROM THE BASIC IR PACK SANHFIRSHF ARE GETTING LINT BALLS ON THEM DURING AN ANGIOGRAM PROCEDURE. THE PARTICULATES ARE ALSO FROM THE FOAM TRAY. THIS IS PROBLEMATIC BECAUSE THEY CAN BECOME AN EMBOLIC FOR THE PATIENT. THERE WAS NO INJURY OR DELAY REPORTED. REPORT BEING FILED FOR POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167830 CPT, BASIC IR PACK (IRSHF)159 RADIOGRAPHIC CONTRAST TRAY OIO MEX03 MEXICO-JUAREZ PRESOURCE SANHFIRSHF UNKNOWN 10888439588224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other