BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B.BRAUN

    MDR report key: 12826785 · Received November 17, 2021

    Report

    Report Number
    2021236-2021-00013
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    November 4, 2021
    Report Date
    February 18, 2022
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    KPE
    UDI-DI
    04046964187797
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) CONTAINER WAS RECEIVED FROM LOT J8K467 (S9900-10) FOR EVALUATION. THE OUTER CLOSURE HAD BEEN REMOVED AND THE STOPPER HAD BEEN PUNCTURED WITH AT LEAST 5ML SOLUTION INSIDE THE BOTTLE. DUE TO THE CONDITION OF THE UNIT IT CANNOT BE TESTED. VISUAL EVALUATION SHOWED NO DEFECTS. A TOTAL OF SEVEN (7) CASES, WITH SIX (6) UNUSED UNITS PER CASE, PLUS TWO (2) SEPARATE UNUSED UNITS WERE RECEIVED, FOR A TOTAL OF 44 UNUSED UNITS. ONE (1) OF THE FORTY-FOUR (44) UNUSED GLASS CONTAINERS WAS FOUND WITH A LOW VACUUM (24.94 IN. HG). THE SPECIFICATION IS A MINIMUM OF 25.5 IN. HG MINIMUM (648 MM). FURTHER INVESTIGATION DETERMINED THE LOW VACUUM WAS DUE TO A CRACK. VISUAL INSPECTION FORTY-THREE (43) UNUSED SAMPLES SHOWED NO CRACKS OR DAMAGED. A REVIEW OF OUR DISCREPANCY MANAGEMENT SYSTEM DATABASE FOUND NO RELATED OR SIMILAR DISCREPANCIES DURING THE PRODUCTION OF THE BATCH. THE CUSTOMER REPORTED AIR IN LINE DURING BLOOD COLLECTION. THIS IS AN OFF-LABEL USE OF THE PRODUCT. THE USED RETURNED UNIT EXHIBITED A CRACK WHICH CAN CAUSE LOSS OF VACUUM. THE LOSS OF VACUUM IS CONFIRMED; HOWEVER, IT IS NOT CONFIRMED THAT THE AIR IN LINE IS DUE TO VACUUM LOSS, AS THE FACILITY WAS USING THE CONTAINER IN AN OFF-LABEL MANNER AND THIS ALSO MAY HAVE CONTRIBUTED TO THE EVENT (TECHNIQUE USED FOR BLOOD COLLECTION). THE LABEL ON THE CONTAINER AND THE IFU BOTH STATE "NOT A BLOOD COLLECTION DEVICE". ADDITIONALLY THE IFU INDICATES TO "CHECK THE BOTTLE FOR CRACKS OR OTHER DAMAGE" AS CRACKS COULD COMPROMISE VACUUM FUNCTIONALITY.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: AIR FILLED THE IV TUBING TOWARD THE PATIENT INSTEAD OF PULLING OUT BLOOD INTO THE BOTTLE. THE PATIENT WENT TO THE ED VIA AMBULANCE FOR HYPOXIA. PATIENT RECEIVED OXYGEN TREATMENT AND FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725646 B.BRAUN CONTAINER, IV KPE B. BRAUN MEDICAL INC S9902-10 J8K467 04046964187797

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Hospitalization