BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5ML, 100UNITS/ML HEPARIN LOCK FLUSH, USP

    MDR report key: 1571158 · Received January 7, 2010

    Report

    Report Number
    2027791-2010-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    May 12, 2009
    Report Date
    January 6, 2010
    Manufacturer
    EXCELSIOR MEDICAL
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXCELSIOR MEDICAL HAS CONDUCTED HEPARIN POTENCY TESTING ON BOTH RETENTION SAMPLES AND CUSTOMER RETURN SAMPLES FROM LOT 67-009-9D. ALL SYRINGES TESTED WERE FOUND TO HAVE HEPARIN CONCENTRATIONS WITHIN SPECIFICATION. ALL AVAILABLE INFORMATION ON THIS INCIDENT WAS FORWARDED TO OUR CLINICAL CONSULTANT, DR. (B)(4) FOR REVIEW AND HE CONCLUDED THAT THE POTENCY OF EXCELSIOR MEDICAL'S HEPARIN WAS NOT THE CAUSE OF CLOGGED PORTS. INFORMATION CONCERNING THE METHOD/TECHNIQUE USED TO LOCK/FLUSH THE PATIENT'S PORTS BEFORE THE CLOGS WERE DISCOVERED WAS PROVIDED BY THE FACILITY IN QUESTION AND IT APPEARS AS THOUGH THE CLINICIANS INVOLVED FOLLOWED THE APPROPRIATE, STANDARD PROCEDURES FOR THE LOCKING/FLUSHING PROTOCOL. TO DATE, THERE HAVE BEEN NO MORE REPORTED INCIDENTS OF CLOGGED PORTS FROM (B)(6) HOSPITAL AND, SEEING AS THE POTENCY OF EXCELSIOR'S PRODUCTS WAS NOT THE ROOT CAUSE OF THIS ISSUE, EXCELSIOR MEDICAL NOW CONSIDERS THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    MDR # 2027791-2009-00004, FILED BY EXCELSIOR MEDICAL ON 06/15/2009, REPORTED THAT 4 PATIENTS AT (B)(6) HOSPITAL IN (B)(6) CAME IN FOR TREATMENT AND DISCOVERED THAT THEIR PORTS WERE CLOGGED. IT WAS REPORTED THAT ALL 4 PATIENTS WERE USING EXCELSIOR HEPARIN PRODUCTS BEFORE THE INCIDENT OCCURRED. THE ORIGINAL MDR WAS FILED IN JUNE OF 2009 TO ENCOMPASS THE ENTIRE EVENT. CURRENTLY, INDIVIDUAL MDR'S ARE BEING GENERATED TO REFLECT THE INCIDENT IN EACH OF THE 4 PATIENTS INVOLVED. THIS REPORT CONSISTS OF INFORMATION REGARDING THE THIRD OF THE FOUR PATIENTS (PATIENT #3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5ML, 100UNITS/ML HEPARIN LOCK FLUSH, USP HEPARIN LOCK FLUSH PRE-FILLED SYRINGE NZW EXCELSIOR MEDICAL 67-009-9D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AREDIA