BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESIGN OPTIONS®

    MDR report key: 24845263 · Received April 10, 2026

    Report

    Report Number
    2521402-2026-00397
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Report Date
    May 4, 2026
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    OGE
    UDI-DI
    04046964186219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). FOUR (4) PHOTOS WERE SUBMITTED TO THE MANUFACTURER FOR EVALUATION. THROUGH VISUAL EXAMINATION OF THE PHOTOS, IT WAS OBSERVED THAT THE EXTRA LABEL ON THE BLISTER PACKAGE IS NOT PLACED ON THE PACKAGE AT THE B. BRAUN MEDICAL INC. PLANT. A REVIEW OF OUR SUPPLY CHAIN AND PACKAGING PROCESSES WAS CONDUCTED; B. BRAUN MEDICAL INC. DOES NOT ATTACH THE LABEL IN QUESTION ON THIS F/G PRODUCT. BASED ON THE INVESTIGATION, THE REPORTED ISSUE IS NOT A RESULT OF OUR PACKAGING OR LABELING PROCESS. THIS PRODUCT IS MANUFACTURED AND PACKAGED AT B. BRAUN MEDICAL INC. AND DISPATCHED TO DISTRIBUTORS. THESE DISTRIBUTORS THEN FORWARD THE PRODUCTS TO THE END CUSTOMERS. THE MOST PROBABLY ROOT CAUSE COULD BE THE DISTRIBUTOR AFFIXES AN ADDITIONAL LABEL, AND REPACKAGED PARTIAL BOXES THAT WERE NOT PART OF B. BRAUN MEDICAL INC.'S ORIGINAL FINISHED GOOD PACKAGING. THE DISTRIBUTOR THEN CONTINUED WITH THEIR HANDLING AND REDISTRIBUTION PROCESS. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NINE (9) UNOPENED SAMPLES AND FOUR (4) PHOTOGRAPHS WERE PROVIDED FOR EVALUATION. ALL SAMPLES AND PHOTOGRAPHS WERE VISUALLY INSPECTED BY THE KITS MRB BUSINESS UNIT, AND IT WAS CONFIRMED THAT THE EXTRA LABEL ON THE BLISTER PACKAGE WAS NOT PLACED ON THE PACKAGE AT THIS MANUFACTURING PLANT. IT SHOULD BE NOTED THAT EIGHT OF THE NINE KITS WERE LABELED FROM B. BRAUN AS ITEM # 551148 LOT # 0062041300, MANUFACTURE DATE 11/24/2025, AND ONE KIT WAS LABELED AS ITEM # 332258 LOT # 0062049877, AND MANUFACTURE DATE 12/19/2025, ALMOST A MONTH APART. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED DEFECT WAS NOT CONFIRMED TO BE A RESULT OF OUR PACKAGING OR LABELING PROCESS. UPON RECEIVING THE SAMPLES AND PHOTOGRAPHS OF THE INCORRECT, EXTRA LABEL ON THE PACKAGING OF THE BLISTERS, A REVIEW OF OUR SUPPLY CHAIN AND PACKAGING PROCESSES WAS CONDUCTED. B BRAUN DOES NOT ATTACH THE LABEL IN QUESTION ON THIS FINISHED GOOD PRODUCT. THIS PRODUCT IS MANUFACTURED AND PACKAGED AT THIS FACILITY AND DISPATCHED TO DISTRIBUTORS. THESE DISTRIBUTORS THEN FORWARD THE PRODUCTS TO THE END CUSTOMERS. THE MOST PROBABLE ROOT CAUSE CAN BE THAT THE DISTRIBUTOR AFFIXES AN ADDITIONAL LABEL, AND REPACKAGED PARTIAL BOXES THAT WERE NOT PART OF B. BRAUN'S ORIGINAL FINISHED GOOD PACKAGING. THE DISTRIBUTOR THEN CONTINUED WITH THEIR HANDLING AND RE-DISTRIBUTION PROCESSES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER RECEIVED PRODUCT LABELED WITH REF. 551148 BUT THERE IS ANOTHER LABEL STICKER ON THE SIDE THAT REFERENCES ID (B)(4). NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372233 DESIGN OPTIONS® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MEDICAL INC. 04046964186219

    Patients

    Seq Age Sex Outcome Treatment
    1