BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAB®

    MDR report key: 24056633 · Received January 13, 2026

    Report

    Report Number
    2021236-2026-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Report Date
    March 30, 2026
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    KPE
    UDI-DI
    04046964187698
    PMA / PMN Number
    K840388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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). 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). THREE (3) PAB CONTAINERS FOR BATCH J5A689/S5904-52 WERE PROVIDED FOR EVALUATION. ALL UNITS WERE OBSERVED TO BE EMPTY. SAMPLES 1 AND 2 WERE RETURNED WITH RED CAP OVER THE ADD PORT, AND SAMPLE 3 WAS ACCESSED AT THE ADD PORT AND DAMAGE TO THE ALUMINUM CAP WAS OBSERVED. THE SAMPLES WERE FURTHER EVALUATED AND THE FOLLOWING WAS DETECTED: SAMPLE 1 HAD EMBEDDED PARTICULATE MATTER, SAMPLE 2 HAD CRACK OBSERVED ON THE BACK OF THE ADD PORT, AND SAMPLE 3 HAD DAMAGE TO THE ALUMINUM CAP; THE ALUMINUM CAP WAS ALSO LOOSE AND WAS MISSING THE GRAY STOPPER. THE CRACK OBSERVED NEAR THE ADD PORT LIKELY OCCURRED DURING ADMINISTRATION/HANDLING OF THE PRODUCT. DAMAGE TO THE ALUMINUM CAP IS LIKELY ATTRIBUTED TO THE MANUFACTURING PROCESS DUE TO THE MISSING STOPPER; AS THIS SHOULD HAVE BEEN DETECTED DURING 100% INSPECTION, RE-TRAINING WILL BE REQUIRED FOR ALL RESPONSIBLE PERSONNEL. THE EMBEDDED PARTICULATE OBSERVED IN SAMPLE 1 WAS OBTAINED AND ITS LENGTH MEASURED. THE PARTICLE WAS FULLY EMBEDDED IN THE BAG AND WOULD NOT HAVE BEEN IN CONTACT WITH THE SOLUTION. THE PARTICLE WAS THEN PLACED IN THE FTIR FOR ANALYSIS, AND RESULTS SHOWED THAT THE LENGTH WAS 232 M, AND THE IDENTIFICATION OF THE PARTICLE WAS THERMALLY DEGRADED MATERIAL. THE SIZE MEASURED OF THE PARTICLE MEETS THE ALLOWABLE PARTICLE SIZE (TAPPI 25 PER 1FT LINEAR SECTION, GELS & INCOMPLETE MELTED PELLETS) PER INTERNAL SPECIFICATIONS. BASED ON THE INVESTIGATIONS REGARDING THE CRACKED CONTAINER, NO ROOT CAUSE WAS FOUND DURING THE B. BRAUN MANUFACTURING PROCESS. THE DEFECT WAS DETERMINED TO BE ASSOCIATED WITH SHIPPING OR HANDLING ISSUES. ALSO, BASED ON THE INVESTIGATIONS FOR THE ONE CRUSH ALUMINUM CRIMP, NO ROOT CAUSE WAS FOUND DURING THE B. BRAUN MANUFACTURING PROCESS RELATED TO A MISSING RUBBER STOPPER IN THE CRIMP. B. BRAUN HAS ESTABLISHED CONTROL PROCESSES IN PLACE FOR SETUP INSPECTIONS, IN-PROGRESS INSPECTIONS, AND AQL SAMPLING. BASED ON THE AVAILABLE DOCUMENTATION, BATCH J5A689 SUCCESSFULLY MET ALL AQL REQUIREMENTS AND FINAL BATCH RELEASE ACCEPTANCE CRITERIA. THIS INCIDENT DOES NOT HAVE AN ADVERSE IMPACT TO THE PRODUCTS ON BATCH J5A689. BATCH RECORDS INDICATE THE BATCH WAS PROCESSED IN FILLING AND PACKING WITH NO DOWNTIME OR EQUIPMENT REPAIRS RELATED TO A FAILURE MODE THAT COULD CAUSE EITHER A CRACK CONTAINER OR A RUBBER STOPPER TO MISS THE CRIMP. ADDITIONALLY, THE RECORDS INDICATE NO NONCONFORMANCE WAS REPORTED FOR THE BATCH IN WHICH THE CONTAINERS WERE FILLED AND PACKED. TWENTY (20) RETAIN UNITS WERE VISUALLY INSPECTED AND NO PARTICULATE MATTER WAS OBSERVED IN THE UNITS. ADDITIONALLY, TWENTY (20) RETAIN UNITS WERE VISUALLY INSPECTED AND NO LEAKAGE OR CONTAINER DAMAGE WAS OBSERVED. 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: DURING COMPOUNDING OF LOT 20251212-21379A, PRIOR TO THE ADDITION OF ACTIVE PHARMACEUTICAL INGREDIANT (API), ONE (1) 150ML PAB BAG WAS DICOVERED WITH A DEFORMED PORT. DURING VISUAL INSPECTION, TWO (2) PAB BAGS WERE NOTED WITH DEFECTS; ONE (1) CONTAINING A BLACK SPOT INSIDE THE BAG AND ANOTHER WITH A CRACK NEAR THE PORT AREA. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117510 PAB® CONTAINER I.V. KPE B. BRAUN MEDICAL INC. J5A689 04046964187698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown