BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL

    MDR report key: 19365581 · Received May 21, 2024

    Report

    Report Number
    1417592-2024-00614
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 22, 2024
    Report Date
    July 17, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    KYZ
    UDI-DI
    40080196031802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO D9: DEVICE RETURNED. UPDATE TO H3: DEVICE EVALUATED. UPDATE TO H6: TYPE OF INVESTIGATION. UPDATE TO H6: INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ON (B)(6) 2024 WHEN ATTEMPTING TO IRRIGATE CLOTS FROM A PATIENT ON A "CBI" THAT HAD CLOTTED OFF THE "PISTON SYRINGE BROKE". THE CUSTOMER REPORTED A NEW SYRINGE WAS OBTAINED AFTER THE REPORTED ISSUE OCCURRED, THE CLOT WAS EVACUATED, AND "CBI CONTINUED". NO ADDITIONAL INFORMATION IS AVAILABLE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024 WHEN ATTEMPTING TO IRRIGATE CLOTS FROM A PATIENT ON A "CBI" THAT HAD CLOTTED OFF THE "PISTON SYRINGE BROKE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516037 TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL KYZ MEDLINE INDUSTRIES, LP 40080196031802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other