BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1080757 · Received July 18, 2008

    Report

    Report Number
    9614279-2008-00027
    Event Type
    Other
    Date Received
    July 18, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 30, 2008
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K760385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLE A THOROUGH EVAL COULD NOT BE PERFORMED. THE HOUSE RETAINS FOR THE REPORTED LOT WERE PHYSICALLY TESTED FOR LEAKAGE AND SUBJECTED TO PULL TEST AT THE BONDED JOINTS. ALL SAMPLES EXCEEDED THE MINIMUM JOINT SEPARATION DESIGN SPECIFICATION AND PASSED THE JOINT INTEGRITY TEST. THERE HAVE BEEN NO OTHER REPORTS OF ANY NATURE AGAINST THIS PROD OR REPORTED LOT NUMBER. NO SPECIFIC CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED ON THE MEDWATCH FORM: "DOCTOR A IS RECEIVING DAILY IV DOSES OF ERTAPENEM FOR TREATMENT OF DOCUMENTED EXTENDED SPECTRUM BETA LACTIMASE E. COLI SEPSIS. HOME HEALTH SUPPLIER APRIA OF RX AND ADMIN MATERIALS CHANGED TO A "SMALLBORE EXTENSION SET" THAT CONNECTS TO THE END OF THE PICC LINE. PREVIOUSLY AN EXTENSION TUBING SET WAS SENT WITH DOCTOR A ATTACHING AN ULTRASITE VALVE TO THE END OF THE TUBING TO PROVIDE ACCESS FOR THE IV ERTAPENEM. THE NEW "SMALLBORE EXTENSION SET" HAS THE ULTRASITE VALVE ALREADY ATTACHED. ON THREE OF FOUR USES OF THIS NEW EXTENSION SET, THE TUBING PROXIMATE END OF THE SET CAME OUT OF THE HUB OF THE SET THAT ATTACHED TO THE PICC LINE, LEAVING AN OPEN ACCESS TO THE PICC LINE. FORTUNATELY THE PICC LINE VALVES WERE CLOSED, BUT DOCTOR A WAS TOLD THAT THE ULTRASITES WERE ONE WAY VALVES AND THAT THE CLAMPS ON THE PICC LINE COULD BE REMOVED AS THEY WERE NOT NEEDED. THE ENDS OF THE TUBING WERE CUT STRAIGHT ACROSS, AND THERE WAS NO EVIDENCE OF PRESSURE AS EACH TIME THEY WERE FOUND DISLOGED, IT WAS WHEN THE STOCKENETTE HOLDING THE LINES IN PLACE WAS REMOVED FOR THE NEXT DOSE OF RX. DOCTOR A HAS TWO SETS OF THE HUBS AND TUBING IF DESIRED FOR EVAL. PICC LINE IN PLACE TO ATTACH TUBING IN QUESTION. USING IV ERTAPENEM FOR THREE MONTH TREATMENTS, AND NEVER HAD PROBLEM WHEN ATTACHED ULTRASITE DIRECTLY TO AN EXTENSION TUBING. FLUSHING EACH USE WITH NORMAL SALINE FOLLOWED BY HEPARIN SALINE. FREQUENCY: USED Q. DAY; ROUTE: IV DRIP; DATES OF USE: 2008; DIAGNOSIS OR REASON FOR USE: E. COLI SEPSIS - EXTENDED SPECTRUM BETA LACTIMASE; EVENT REAPPEARED AFTER REINTRODUCTION? YES." NOTE: THE NATURE OF THE INCIDENT IS UNCLEAR AS REPORTED ON THE MEDWATCH FORM AND THERE IS NO CONTACT INFO PROVIDED IN WHICH TO FOLLOW UP WITH THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA SMALLBORE EXTENSION SET FPA B. BRAUN DOMINICAN REPUBLIC NA 60978573

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other