BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON PUMP SYRINGE ADD-ON SET

    MDR report key: 818614 · Received February 2, 2007

    Report

    Report Number
    2647836-2007-00001
    Event Type
    Other
    Date Received
    February 2, 2007
    Date of Event
    December 14, 2006
    Report Date
    January 29, 2007
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE TUBING WAS SEPARATED FROM THE SMALLBORE SPIN LOCK ASSEMBLY OF THE SET, DUE TO INSUFFICIENT SOLVENT APPLICATION APPLIED AT THE JOINT CONNECTION DURING ASSEMBLY. THE O.D. OF THE TUBING AND THE CRITICAL DIMENSION OF THE SPINLOCK TUBING INSERTION AREA WERE MEASURED PER THE APPLICABLE DESIGN SPECIFICATIONS AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: ADMINISTERING LIPIDS TO A PREEMIE- TUBING DISCONNECTED FROM DISTAL CONNECTOR. RESULTED IN INFUSION SOLUTION LOSS. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE INFANT IS FINE AND SUFFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. THE LOT NUMBER REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON PUMP SYRINGE ADD-ON SET HORIZON PUMP EXTENSION SET FPA B. BRAUN MEDICAL INC. ET82HP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other