BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL EPIDURAL KIT

    MDR report key: 17745596 · Received September 13, 2023

    Report

    Report Number
    MW5145646
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 8, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT.
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER ON 10/2/2023 FOR REPORT MW5145646 TO CHANGE THE MANUFACTURER TO MEDLINE. REFER TO ADD'L DOCUMENTS IN I2K.

    Description of Event or Problem · 0

    EPIDURAL GLASS SYRINGE POORLY FUNCTIONING WITH LOSS OF RESISTANCE TO SALINE RESULTING IN DURAL PUNCTURE DURING EPIDURAL PLACEMENT. AS WELL, CARDINAL KITS ARE FREQUENTLY LACKING SPECIFIC COMPONENTS IE MEDICATIONS AND EPIDURAL CONNECTORS. EPIDURAL KITS FREQUENTLY MISLABELED AS TO EQUIPMENT NOT AVAILABLE IN KIT RESULTING IN DELAYED PLACEMENT AND TIME TO ANALGESIA FOR LABORING MOTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330745 CARDINAL EPIDURAL KIT EPIDURAL ANESTHESIA KIT OGE MEDLINE INDUSTRIES, LP - SPT.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female