BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 14603880 · Received June 6, 2022

    Report

    Report Number
    1036844-2022-00044
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 31, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    BSO
    UDI-DI
    10801902189117
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND AMPULES WITH A POTENTIALLY RELEVANT FINDING. A NONCONFORMANCVE INITIATED FOR COMPONENT K-07800-005; LOT # 23P22A0075 IN REGARD TO THE EXPIRATION DATE 6 MONTHS SHORT OF SPECIFIED REQUIREMENT. NOT RELEVANT TO THIS COMPLAINT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND AMPULES WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THIS EPIDURAL KIT WAS OPENED AND CONTAINED AN OPEN, EMPTY GLASS AMPULE THAT SHOULD HAVE CONTAINED SALINE. THE SOLUTION APPEARED TO HAVE DRIED AND NOTHING WAS WET IN THE KIT.

    Description of Event or Problem · 0

    THIS EPIDURAL KIT WAS OPENED AND CONTAINED AN OPEN, EMPTY GLASS AMPULE THAT SHOULD HAVE CONTAINED SALINE. THE SOLUTION APPEARED TO HAVE DRIED AND NOTHING WAS WET IN THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226998 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL LLC IPN919609 23F22B0003 10801902189117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.