BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAB ®

    MDR report key: 23168971 · Received September 29, 2025

    Report

    Report Number
    2021236-2025-00014
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Report Date
    September 29, 2025
    Manufacturer
    B. BRAUN MEDICAL INC - IRVINE
    Product Code
    KPE
    PMA / PMN Number
    K840388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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). A B. BRAUN CASE (SEQUENTIAL #: (B)(4) WAS RECEIVED WITH A TOTAL OF FOURTY-FOUR (44) INTACT PAB UNITS FROM LOT: J4S670 (S5904-52). THE PAB MIXING CONTAINERS WERE SUBMERGED IN WATER, AND NO SIGNS OF LEAKAGE WERE DETECTED. PER THE PAB SUBJECT MATTER EXPERT (SME) EVALUATION, THERE WAS NO DEFECT OBSERVED ON THE RETURNED UNITS SUCH AS PARTICULATE MATTER. THE RESIDUAL FLUID OBSERVED IN THE PAB EMPTY CONTAINER WAS DETERMINED TO BE MOISTURE/DROPLETS INSIDE, AND THIS IS NORMAL FOR STERILIZATION PURPOSES. ACCORDING TO THE PAB MIXING CONTAINER 150 ML DIRECTIONS FOR USE: CONTAINS A SMALL AMOUNT OF WATER FOR STEAM STERILIZATION, WHICH IS CONSIDERED NORMAL. THIS RESIDUAL FLUID IS PART OF THE STERILIZATION PROCESS AND DOES NOT COMPROMISE THE INTEGRITY OR SAFETY OF THE PRODUCT. REVIEW ON THE NON-CONFORMANCE SYSTEM DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCE'S 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 USER FACILITY: THE CUSTOMER ORDERS THE EMPTY 150 ML PAB MIXING CONTAINER, AND RESIDUAL CLEAR FLUID WAS OBSERVED IN THE BAGS FROM LOT: J4S670. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524697 PAB ® CONTAINER I.V. KPE B. BRAUN MEDICAL INC - IRVINE J4S670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown