BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1874265 · Received October 14, 2010

    Report

    Report Number
    2523676-2010-00070
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 7, 2010
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    LHI
    PMA / PMN Number
    K820453
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. ONE UNUSED SAMPLE WAS RETURNED FROM THE REPORTED LOT AND FOURTEEN UNUSED SAMPLES WERE RETURNED FROM ANOTHER LOT, NOT INITIALLY REPORTED. NO VISUAL MANUFACTURING DEFECTS WERE NOTED. THE NEEDLE USED TO ACCESS THE STOPPLE WAS NOT RETURNED. THE UNUSED RETURNED SAMPLES WERE PHYSICALLY PRESSURE TESTED FOR LEAKAGE PER SPECIFICATION. ALSO A RESEAL TEST WAS PERFORMED PER SPECIFICATION. ALL RETURNED SAMPLES PASSED ALL PHYSICAL TESTING. NO LEAKS WERE NOTED THROUGH THE INJECTION SITE. THE HOUSE RETAIN SAMPLES FROM BOTH LOTS WERE ALSO PHYSICALLY TESTED AND PASSED ALL TESTING. ACTUAL USAGE WAS SIMULATED USING A 21 GAGE NEEDLE THAT IS SUPPLIED IN OUR KITS. ALL INJECTION SITES WERE ACCESSED FIVE (5) TIMES AS WAS REPORTED BY THE FACILITY. ALL INJECTION SITES RESEALED AND NO LEAKS WERE NOTED. WITHOUT THE ACTUAL SAMPLE OR THE NEEDLE THE FACILITY WAS USING TO ACCESS THE INJECTION SITE, THE EXACT NATURE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER OR THE REPORTED LOT NUMBERS. WE CONTINUOUSLY MONITOR PRODUCT INCIDENT REPORTS TO IDENTIFY TRENDS WHICH MIGHT AFFECT THE QUALITY OF OUR PRODUCTS. AS THERE ARE NO OTHER SIMILAR REPORTS OF THIS NATURE, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF ADDITIONAL INFO OR SAMPLES OF THE NEEDLE USED TO ACCESS THE STOPPLE BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. ADDITIONAL INFO: ADD'L LOT# 61117902, EXPIRATION DATE: 05/31/2015.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NUCLEAR MEDICATION IS LEAKING FROM STOPPLE OF PRODUCT. EACH STOPPLE IS ACCESSED 4 TO 5 TIMES WITH A 21 GAUGE NEEDLE, THE LEAKING IS NOTICED AFTER THE 3RD PUNCTURE. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THERE WAS NO PT CONTACT WITH THE NUCLEAR MEDICINE LEAK, HOWEVER, THE MEDICINE DID DRIP ONTO THE FLOOR AND THE ROOM HAD TO BE CLOSED FOR A DAY DUE TO THE SPILL. NO ONE SUFFERED ANY ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT. IT WAS ALSO REPORTED THE FACILITY IS USING A 21 GA NEEDLE SUPPLIED BY (B)(6) AND NOT A B. BRAUN NEEDLE. SAMPLES OF THE NEEDLE WILL NOT BE SENT AT THIS TIME. NO FURTHER INCIDENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA IN 2000 INT STOPPER LHI B. BRAUN MEDICAL INC. NA 61124056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other