BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 999242 · Received February 14, 2008

    Report

    Report Number
    2523676-2008-00004
    Event Type
    Injury
    Date Received
    February 14, 2008
    Report Date
    February 5, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    NGT
    PMA / PMN Number
    K002142
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT#: 070915A, 070924A AND 071002A. ADD'L EXPIRATION DATE: 10/31/2009. ON JANUARY 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS 7 PTS WITH DOCUMENTED CASES OF SERRATIA ALL FROM THE HEMODIALYSIS UNIT OF THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NORMAL SALINE IV FLUSH, 10ML NGT B. BRAUN MEDICAL, INC. NA 070917A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other