BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OB PACK

    MDR report key: 22087801 · Received May 27, 2025

    Report

    Report Number
    1423395-2025-00045
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 27, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OKV
    Product Problem
    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. A SAMPLE WAS REQUESTED FOR EVALUATION. 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".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333476 OB PACK OKV MEDLINE INDUSTRIES, LP 25CBI796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown