BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1051478 · Received May 16, 2008

    Report

    Report Number
    2523676-2008-00037
    Event Type
    Injury
    Date Received
    May 16, 2008
    Report Date
    May 6, 2008
    Manufacturer
    *
    Product Code
    NGT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/17/2007, BBMI - RECEIVED A NATIONWIDE RECALL NOTIFICATION FROM AM2PAT INC. INITIATING A NATIONWIDE RECALL OF ALL LOTS OF HEPARIN AND SALINE PRE-FILLED SYRINGES, WHICH INCLUDED CATALOG #513587. AM2PAT INC MANUFACTURES THESE PRE-FILLED SYRINGES UNDER BOTH THEIR PRIVATE LABEL, SIERRA PRE-FILLED INC., AS WELL AS UNDER THE B.BRAUN MEDICAL INC. LABEL. BASED ON AN ONGOING FDA INSPECTION OF AM2PAT INC'S FACILITY, IT HAS BEEN DETERMINED THAT THERE IS A POTENTIAL FOR THE STERILITY OF THESE LOTS TO BE COMPROMISED. B.BRAUN INC. IMMEDIATELY NOTIFIED ALL CUSTOMERS OF THIS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * NORMAL SALINE IV FLUSH, 10ML NGT * NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other