BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYREX PRE-FILLED SYRINGE

    MDR report key: 1034947 · Received April 28, 2008

    Report

    Report Number
    2027791-2008-00003
    Event Type
    Other
    Date Received
    April 28, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 28, 2008
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, EXCELSIOR HAS NOT RECEIVED ANY ADVERSE EVENT REPORTS INVOLVING SYSTEMIC INFECTIONS RESULTING FROM USE OF OUR HEPARIN LINE OF PRODUCTS. ADDITIONALLY, THE SYMPTOMS REPORTED BY THE COMPLAINANT DO NOT MATCH THOSE NORMALLY SEEN IN PTS EXPOSED TO CONTAMINATED HEPARIN. THE LIST OF ADVERSE REACTIONS CONTAINED IN EXCELSIOR'S PRODUCT INSERT DOES NOT INCLUDE THE SYMPTOMS REPORTED BY THE COMPLAINANT. TELEPHONE CONVERSATIONS WITH THE COMPLAINANT'S PHARMACY REVEALED THAT THEY DO NOT KNOW THE LOT NUMBERS OF THE SYRINGES RECEIVED BY PT, NOR CAN THEY CONFIRM THAT HER LAST SHIPMENT OF HEPARIN PRODUCT WAS ACTUALLY AN EXCELSIOR LOT. A SECOND PHONE CALL TO THE SAME FACILITY DISCOVERED THAT THEY WERE DISPENSING BBRAUN/SIERRA SYRINGES ALONG WITH EXCELSIOR BRANDED PRODUCTS UP UNTIL THE BBRAUN/SIERRA STOCK WAS RECALLED. THEIR PHARMACY TECHNICIAN NOTED THAT THEY HAD TO PHYSICALLY REMOVE THE RECALLED SYRINGES FROM PTS' HOMES, HOWEVER, THEY COULD NOT CONFIRM WHETHER OR NOT PT WAS RECEIVING EITHER BBRAUN/SIERRA OR EXCELSIOR SYRINGES AT THAT TIME. AT THIS POINT, EXCELSIOR IS FILING THIS MDR AS AN INITIAL NOTIFICATION OF THIS INCIDENT. WE ARE CURRENTLY WORKING WITH PT AND HER HOSPITAL AND PHARMACY TO GATHER AS MUCH INFO AS POSSIBLE ON THIS SITUATION. WE WILL PROVIDE FURTHER UPDATES FOR THIS ADVERSE EVENT AS NEW AND RELEVANT DATA BECOMES AVAILABLE TO US. NOTE: DEVICE COULD NOT BE EVALUATED BECAUSE IT WAS NOT RETURNED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE PT STATED THAT SHE HAS BEEN SICK FOR THE LAST 2 YEARS. SHE WAS IN THE HOSPITAL ON TWO DIFFERENT OCCASIONS, FOR A TOTAL OF 75 DAYS, WITH A BLOOD INFECTION. HER FIRST HOSPITAL STAY WAS IN 2006, WHICH LASTED FOR A PERIOD OF 42 DAYS. THE BLOOD INFECTION SHE EXPERIENCED DURING THIS TIME PERIOD WAS FOR HER FIRST PICC LINE. THE SECOND HOSPITALIZATION EVENT OCCURRED IN 2007 AND LASTED FOR 37 DAYS. SHE MENTIONED THAT ON BOTH OCCASIONS SHE HAD TWO DIFFERENT BLOOD INFECTIONS AND EACH TIME THE END OF THE PICC LINE WAS CULTURED, REVEALING BACTERIAL CONTAMINATION ON THE PORT THAT LED TO HER MASSIVE BLOOD INFECTIONS. SHE ALSO MENTIONED THAT SHE HAD FOUR ANGIOPLASTIES IN THE PAST 90 DAYS. SHE WAS ADMITTED TO HOSP FOR POOR VASCULAR VEINS. HER SUPERIOR VENA CAVA HAS EXTREME DAMAGE AND HER PHYSICIANS ARE NOT SURE WHY. WE HAVE ASKED THE QUESTIONS SUPPLIED BY THE FDA. I ALSO ASKED IF WE COULD CONTACT PT'S DR(S) AND THE PHARMACY SHE RECEIVED THE FLUSHES FROM. SHE SAID IT WOULD BE OKAY. PT WAS NOT SURE OF THE LOT NUMBERS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYREX PRE-FILLED SYRINGE 100U/ML HEPARIN LOCK FLUSH SYRINGE NZW EXCELSIOR MEDICAL CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other