BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-CATH

    MDR report key: 256117 · Received December 27, 1999

    Report

    Report Number
    2925153-1999-00008
    Event Type
    Injury
    Date Received
    December 27, 1999
    Date of Event
    February 1, 1999
    Report Date
    December 27, 1999
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BASED ON THE REPORT RECEIVED ON 12/23/1999, TWO (2) BABIES DIED OF "PERICARDIAL TAMPONADE" AT THE HOSP DURING THE LAST 12 MONTHS. THE FIRST OCCURRED IN FEB 1999, OF A 6 WEEK OLD, AND THE SECOND OCCURRED IN DEC 1999, OF AN 11 DAY OLD. THE FIRST WAS NOT REPORTED TO HDC. ADD'L DATA/INFO IS TO BE PROVIDED TO HDC. HDC CATHETERS HAD BEEN USED FOR/DURING THE BABIES' TREATMENT.

    Description of Event or Problem · 2

    BASED ON THE REPORT RECEIVED ON 12/23/1999, TWO (2) BABIES DIED OF "PERICARDIAL TAMPONADE" AT THE HOSP DURING THE LAST 12 MONTHS. THE FIRST OCCURRED IN FEB 1999, OF A 6 WEEK OLD, AND THE SECOND OCCURRED IN DEC 1999, OF AN 11 DAY OLD. THE FIRST WAS NOT REPORTED TO HDC. ADD'L DATA/INFO IS TO BE PROVIDED TO HDC. HDC CATHETERS HAD BEEN USED FOR/DURING THE BABIES' TREATMENT. DATE OF EVENT: 12/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC DQO HDC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5 MO Death
    2 11 DAY Death
    3