BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN PREFILL

    MDR report key: 3432179 · Received October 22, 2013

    Report

    Report Number
    1282497-2013-00042
    Event Type
    Other
    Date Received
    October 22, 2013
    Report Date
    October 16, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    NGT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. MEDWATCH (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A HOME CARE PT HAD AN ISSUE WITH A PRE-FILL SYRINGE. THE CUSTOMER REPORTS THIS PRODUCT IS USED WITH HER PT AS A CENTRAL PORT FLUSH. THE PT USED BOTH PRODUCTS NORMAL SALINE FLUSH AND HEPARIN FLUSH. AT THE TIME OF THE REPORT, THE PT WAS IN THE HOSPITAL WITH CENTRAL LINE/PORT INFECTIONS AND BLOOD CULTURES CAME BACK POSITIVE FOR BOTH CULTURES; ONE CULTURE THROUGH THE CENTRAL LINE AND THE SECOND PERIPHERALLY. THEY HAVE BEEN USING RECALLED FLUSHED IN THEIR STOCK UP UNTIL THEY FOUND OUT ABOUT THE RECALL. THE NORMAL SALINE FLUSH AND HEPARIN FLUSH HAVE BEEN USED FOR THE PAST 12 YEARS. THE PT HAS THE CENTRAL LINE DUE TO THE FACT THAT HE HAD A LUNG TRANSPLANT AND REFLUX ESOPHAGITIS. THE PT WAS PREVIOUSLY FED VIA TPN BUT NOW RECEIVES HYDRATION THROUGH HIS PORT. THE PT IS RECEIVING D2.5 AND ONE HALF NORMAL SALINE THROUGH HIS PORT. THE PT WAS RECEIVING ANTIBIOTICS WHILE IN THE HOSPITAL AND THE CUSTOMER STATED SHE COULD NOT RECALL THE TYPE OF MEDICATION. THE PT HAS SINCE BEEN RELEASED FROM THE HOSPITAL. PER ADDITIONAL INFO RECEIVED ON (B)(6) 2013, THE BACTERIA CULTURE CAME BACK POSITIVE FOR ENTEROBACTER CLOACAE. THE PT IS DOING MUCH BETTER. THEY ARE TRYING NOT TO UTILIZE THE PT'S PORT AS MUCH DUE TO THREE PREVIOUS INFECTIONS OVER THE COURSE OF THE SUMMER. THE PT IS RECEIVING PEDIALYTE VIA THE J-TUBE AND AS A PROPHYLAXIS, ETHANOL FLUSHED TO HELP PREVENT FURTHER INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539967 UNKNOWN PREFILL UNKNOWN PREFILL NGT COVIDIEN LP UNK PREFILL BA0084N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other