BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OB PACK

    MDR report key: 22123217 · Received June 2, 2025

    Report

    Report Number
    1423395-2025-00050
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    May 7, 2025
    Report Date
    June 2, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OKV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY THE BULB SYRINGE IS "COMPRESSED AND DOES NOT INFLATE". PER THE FACILITY "WE STOCK EXTRA BULB SYRINGE IN OUR DELIVERY WARMERS, SO WE USED THEM INSTEAD". PER THE FACILITY THERE WAS NO REPORTED INJURY OR MEDICAL INTERVENTION REQUIRED. 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

    ACCORDING TO THE FACILITY THE BULB SYRINGE IS "COMPRESSED AND DOES NOT INFLATE". PER THE FACILITY "WE STOCK EXTRA BULB SYRINGE IN OUR DELIVERY WARMERS, SO WE USED THEM INSTEAD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26993 OB PACK OKV MEDLINE INDUSTRIES, LP 25CBI796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other