BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE

    MDR report key: 17531559 · Received August 12, 2023

    Report

    Report Number
    MW5138473
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    July 1, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    DXF
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF RECEIPT OF INFORMATION ABOUT AN ADVERSE EVENT REGARDING A PRODUCT WHICH ABBOTT DID NOT MANUFACTURE OR IMPORT. THE REPORT COMES FROM DR (B)(6) AT (B)(6) CONCERNING A BAYLIS NEEDLE MANUFACTURED BY BAYLIS MEDICAL. PLEASE SEE EVENT DESCRIPTION BELOW FOR MORE DETAILS: DURING THE PROCEDURE, WHILE MAPPING IN THE LEFT ATRIUM, A POSTERIOR LEFT ATRIAL PERICARDIAL EFFUSION WAS NOTED. PROTAMINE WAS GIVEN AND AN ECHOCARDIOGRAM WAS PERFORMED. IT WAS FOUND THAT PATIENT HAD THIS AS A BASELINE EFFUSION SINCE 2017. TWO DIFFICULT TRANSSEPTAL PUNCTURE ATTEMPTS WITH A THE BAYLIS NEEDLE WERE CONDUCTED AND BELIEVED TO HAVE CAUSED ANY ADDITIONAL EFFUSION PAST THE BASELINE ONE PRESENT SINCE 2017. THE PATIENT STABLE THROUGHOUT AND NO PERICARDIOCENTESIS WAS NEEDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354334 NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown