BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV ADMINISTRATION SET

    MDR report key: 10379142 · Received August 7, 2020

    Report

    Report Number
    2523676-2020-00217
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 24, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    PMA / PMN Number
    K173361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO PHOTOS OR VIDEOS WERE PROVIDED FOR EVALUATION. ENVIRONMENTAL MONITORING RECORDS WERE REVIEWED ON BOTH EXTRUSION AND ASSEMBLY LINES AND WERE FOUND TO BE WITHIN ACCEPTABLE PARAMETERS. STERILIZATION RECORDS WERE ALSO REVIEWED AND DEEMED ACCEPTABLE. THE RETAIN SAMPLES WERE VISUALLY EVALUATED WITH NO DEFECTS NOTED. OCCLUSION TESTING WAS PERFORMED WITH PASSING RESULTS. SAMPLES WERE EVALUATED FOR LEAKAGE PER TP-MD-2000528 WITH NO DEVIATIONS FROM ESTABLISHED SPECIFICATIONS. THE BEFORE AND AFTER ADJACENT LOTS (0061707105 AND 0061718171) WERE TESTED PER SPECIFICATION WITH PASSING RESULTS. IN ADDITION, THE END CUSTOMER COMMUNICATED THEY HAVE TRACED THE REPORTED ISSUE BACK TO A SPECIFIC LOT OF VITAMINS USED DURING INFUSIONS. FURTHERMORE, THEY HAVE INDICATED TO HAVE CONCLUDED INVESTIGATIONS INTO THE DEVICE (CATALOGUE #V1415-15) AS A POTENTIAL SOURCE OF THE REPORTED PATIENT REACTIONS AND HAVE RESUMED PROVIDING INFUSIONS TO PATIENTS WITH NO FURTHER ISSUES. THE DATA FROM OUR INVESTIGATION DOES NOT SUPPORT THE CONCLUSION THAT THE MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE DESCRIBED ADVERSE REACTION. THE PRODUCT MET ALL REQUIRED ACCEPTANCE CRITERIA AND THERE WERE NO IDENTIFIED DISCREPANCIES OR DEVIATIONS IN THE MANUFACTURING RECORDS OR IN THE EVALUATED HOUSE RETAIN SAMPLES. INFORMATION RECEIVED FROM THE USER FACILITY SUGGESTS THAT THE ROOT CAUSE MAY BE ATTRIBUTABLE TO A VITAMIN PRODUCED BY ANOTHER MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT FOUR OF B. BRAUN MEDICAL INTERNAL REPORT NUMBER (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 · 1

    AS REPORTED PER HEALTH (B)(6) INQUIRY (HC #(B)(4)): SIX (6) PATIENTS PRESENTED TO A LOCAL EMERGENCY DEPARTMENT WITHIN 24 HOURS OF RECEIVING AN INFUSION OF VITAMINS FROM A NATUROPATH. THEY PRESENTED WITH VARIOUS DEGREES OF SYMPTOMS INCLUDING FLU-LIKE SYMPTOMS, DIARRHEA, NAUSEA AND HEPATITIS. ALL PATIENTS WHO RECEIVED THIS TREATMENT WERE THEN INTERVIEWED AND 17 OF THE 18 DEVELOPED SYMPTOMS FROM 30 MINUTES TO 24 HOURS AFTER THE INFUSION. ALL HAVE RECOVERED. THE INVESTIGATION EXPANDED TO INCLUDE ANOTHER CITY IN WHICH THIS NATUROPATH PRACTICED, AND MORE CASES WERE IDENTIFIED WITH SIMILAR SYMPTOM COMPLEX AND TIMING. THE PRODUCT WAS CONFISCATED UNDER THE HEALTH PROTECTION ACT WITH PROPER CHAIN OF CUSTODY. THEY ARE CONTINUING THEIR INVESTIGATION TO DETERMINE WHETHER THIS IS A BATCH ISSUE , A PRACTICE SAFETY ISSUE, OR OTHER. A REPORT IS BEING FILED FOR EACH OF THE PATIENTS WHO EXHIBITED SYMPTOMS, AS EACH PATIENT WOULD REPRESENT A SEPARATE EVENT, FOR A TOTAL OF 17 EVENTS. THIS REPORT IS BEING FILED FOR EVENT 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841756 IV ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC. 0061717018

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O