BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGRAPHY FOAKS

    MDR report key: 19113381 · Received April 15, 2024

    Report

    Report Number
    1423395-2024-00394
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 25, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INCORRECT INFORMATION PROVIDED REGARDING A SYRINGE COMPONENT WITHIN DYNJ63573. THE REPORTED PARTICULATE FOUND WITHIN A SYRINGE FLUID PATHWAY OCCURRED WITH A SYRINGE COMPONENT WITHIN PRODUCT DYNJ63576A AND WAS REPORTED UNDER MEDWATCH REPORT #1423395-2024-00395. THERE WAS NO REPORTED ISSUE WITH A SYRINGE WITHIN PRODUCT DYNJ63573. PLEASE REFER TO MEDWATCH REPORT #1423395-2024-00395 FOR DETAILS REGARDING THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT PARTICULATE WAS FOUND "INSIDE" THE SYRINGE PRIOR TO USE ON THE PATIENT. 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 PARTICULATE WAS FOUND "INSIDE" THE SYRINGE PRIOR TO USE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581209 ANGIOGRAPHY FOAKS OJG MEDLINE INDUSTRIES LP 23KBK058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other