BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11028986 · Received December 17, 2020

    Report

    Report Number
    1423395-2020-00037
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OGR
    UDI-DI
    10193489222685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EMAIL RECEIVED BY VANDERBILT UNIVERSITY MEDICAL CENTER, WITH ADDITIONAL INFORMATION RELATED TO THIS INCIDENT. IT WAS REPORTED, "THE TIP OF A SYRINGE BROKE OFF AND GOT STUCK INSIDE THE LUMEN OF A PIGTAIL CATHETER." REPORTER CONFIRMS THE INCIDENT OCCURRED (B)(6) 2020. REPORTER STATES, "THE PIGTAIL CATHETER WAS REMOVED AND A NEW ONE WAS REPLACED. THE PATIENT WAS UNDER GENERAL ANESTHESIA, NO MORE MEDICATION WAS NEEDED." REPORTING FACILITY HAS INDICATED THAT THE SYRINGE, PIGTAIL, AND LOT NUMBER OF THE PACK ARE ALL AVAILABLE FOR RETURN AND EVALUATION. CURRENTLY AWAITING INVESTIGATION RESULTS. NO FURTHER INFORMATION. DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE TIP OF A SYRINGE BROKE OFF AND GOT STUCK INSIDE THE LUMEN OF A PIGTAIL CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498861 MEDLINE INDUSTRIES, INC. DBD-EP FEMORAL PACK SAFETY 1 OGR MEDLINE INDUSTRIES INC. DYNJ54701B 20EBV379 10193489222685

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention