BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1120711 · Received August 14, 2008

    Report

    Report Number
    2523676-2008-00074
    Event Type
    Other
    Date Received
    August 14, 2008
    Report Date
    August 13, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    NZW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B) (6) 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 # 513612. AM2PAT INC. MANUFACTURED 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 FDA INSPECTION OF AM2PAT INC.'S FACILITY, IT HAD 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. ADD'L LOT NUMBERS AND EXPIRATION DATES: 070217H / 2/28/2009, 060505H / 5/31/2008.

    Description of Event or Problem · 1

    INCIDENT REPORTED BY (B) (6)'S WIFE, (B) (6): (B) (6) WAS RECEIVING FLUSHES TWICE DAILY. DEVELOPED HIGH FEVER (104) FOR SEVERAL DAYS AND RAISED RED ITCHY RASH, REQUIRING ANTIBIOTICS. HE WAS A PT AT (B) (6)/(B) (6)- (B) (6) INDICATED THAT THE SYRINGES WERE PROVIDED BY (B) (6). (B) (6) STILL HAS THE RAISED RED ITCHY RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA HEPARIN LOCK FLUSH SOLUTION 5 ML NZW B. BRAUN MEDICAL, INC. NA 070504H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other