BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXGUARD EXTENSION SET

    MDR report key: 3162025 · Received May 29, 2013

    Report

    Report Number
    9616066-2013-00388
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AFFECTED PRODUCT WAS NOT SAVED AND WILL NOT BE RETURNED FOR EVAL. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED CRACKED CONNECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CRACKED CONNECTOR OCCURRED IN THE NICU. THE CONNECTOR WAS ATTACHED TO A PICC CATHETER. SOLUTIONS INFUSING WERE TPN AND INTRALIPIDS. THE CUSTOMER ALSO REPORTED THAT BLOOD CULTURES WERE DRAWN AND IV ANTIBIOTICS WERE STARTED SINCE THE T-CONNECTOR WAS DIRECTLY CONNECTED TO THE PICC AND CONSIDERED TO BE PART OF THE LINE. NO FURTHER PT OR EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234341 MAXGUARD EXTENSION SET FPA CAREFUSION CORPORATION ME1257 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PICC CATHETER: MFR, MODEL, LOT UNK