BEUDAMED
    FDA Adverse Event Other Summary report: N

    IV EVACUATED CONTAINER

    MDR report key: 3042453 · Received January 9, 2013

    Report

    Report Number
    2021236-2013-00001
    Event Type
    Other
    Date Received
    January 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 9, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    PRE-AMEND
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    END USER DID NOT FOLLOW DIRECTIONS FOR USE OR PRODUCT LABELING. UNKNOWN IF ANY OTHER CONTRIBUTORS TO THE EVENT. NO SAMPLE WAS RETURNED FOR EVAL AND NO LOT NUMBER INFO WAS AVAILABLE; THEREFORE NO UNUSED OR RETAINED UNITS COULD BE EVALUATED. THE PRODUCT LABEL OF THE B BRAUN GLASS IV EVACUATED CONTAINERS READS "NOT A BLOOD COLLECTION DEVICE". PER DIRECTIONS FOR USE, UNDER WARNINGS SECTION: "EMPTY EVACUATED CONTAINERS ARE NOT INTENDED FOR USE AS A BLOOD COLLECTION DEVICE, FOR PARACENTESIS OR BODY FLUID WITHDRAWAL." THE END CUSTOMER WAS USING THE CONTAINER FOR AN OFF-LABEL USE. THE PURPOSE OF THE CONTAINER IS FOR ADMIXING PRODUCT. ON (B)(4) 2013 SPOKE ON TELEPHONE WITH REPORTER WHO WILL ATTEMPT TO GATHER THE INFO REQUESTED. SHE HAS BEEN OUT OF THE OFFICE AND JUST RETURNED. REPORTER DID STATE THAT DUE TO CONFIDENTIALITY, THEY WILL NOT SUPPLY A PT IDENTIFIER. AS OF (B)(4) 2013 NO FURTHER INFO FROM REPORTER.

    Description of Event or Problem · 1

    PER (B)(4): RECEIVED ALTERNATE 500ML VACUUM BOTTLE FROM STORES AND DISTRIBUTION. DURING THE PROCESS OF THERAPEUTIC PHLEBOTOMY FOR THIS PT, THE PT REPORTED FEELING LIGHT-HEADED, CLAMP WAS PLACED ON THE TUBING TO SLOW THE PROCESS DOWN. THE IV WAS RE-POSITIONED AND AT THAT TIME THE SUCTION FROM THE VACUUM BOTTLE APPEARED TO REVERSE AND PULL AIR UP THROUGH THE TUBING BACK TOWARDS THE IV CATHETER. TUBING WAS IMMEDIATELY CLAMPED. PT REPORTED FEELING A "WEIRD SENSATION" NEAR THE IV SITE. AN EXCELLENT BLOOD RETURN WAS PRESENT. A NEW PHLEBOTOMY SETUP WAS ATTACHED TO THE EXISTING IV CATHETER. ADD'L INFO FROM REPORTER (B)(6) 2012: THE PT IS OK AND WAS DISCHARGED AMBULATING INDEPENDENTLY FROM THE INFUSION CENTER. THE NURSE ASSIGNED TO THE PT ALSO CALLED THE PT THE NEXT DAY TO CHECK IN ON HIM AND LEARNED HE WAS DOING FINE AND HAD NO COMPLAINTS. THE IMMEDIATE TREATMENT THAT OCCURRED WAS THE NEEDLE WAS REMOVED AND THE NURSE ATTEMPTED TO REMOVE ANY POSSIBLE AIR THAT MAY HAVE ENTERED THE PTS' BLOODSTREAM IN AN ATTEMPT TO PREVENT A POSSIBLE AIR EMBOLISM. CONTAINER WAS POSITIONED ON THE FLOOR WHICH IS STANDARD PRACTICE FOR THERAPEUTIC PHLEBOTOMIES FOR YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13493 IV EVACUATED CONTAINER EMPTY IV GLASS CONTAINER FPA B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention