BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAB®

    MDR report key: 21324409 · Received February 6, 2025

    Report

    Report Number
    2021236-2025-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 9, 2025
    Report Date
    May 30, 2025
    Manufacturer
    B. BRAUN MEDICAL INC - IRVINE
    Product Code
    KPE
    UDI-DI
    04046964187698
    PMA / PMN Number
    K840388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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). FIVE (5) PAB UNITS FROM LOT J4N717/S5904-52 WERE RECEIVED FOR EVALUATION. THE UNITS WERE EMPTY, THE ADD PORT CAPS WERE REMOVED, AND THE PORTS HAD BEEN ACCESSED. THROUGH VISUAL OBSERVATION, PARTICULATE MATTER (PM) WAS OBSERVED IN THE UNITS. ALL OF THE SAMPLES WERE SENT TO PHOTOMETRICS FOR FURTHER ANALYSIS AND IDENTIFICATION. OPTICAL IMAGES OF THE PARTICLES WERE TAKEN, AND ITS LENGTHS WERE MEASURED. ADDITIONALLY, THE PARTICLES WERE PLACED IN THE FOURIER TRANSFORM INFRARED SPECTROSCOPE (FTIR) AND/OR IN THE SCANNING ELECTRON MICROSCOPE (SEM) FOR ENERGY DISPERSIVE X-RAY SPECTROSCOPY (EDS) ANALYSIS. THE RESULTS ARE SHOWN BELOW. PAB UNIT #1 PARTICLE 1- MEASURED 4.04 MM AND WAS IDENTIFIED AS CELLULOSE (COTTON FIBER) AND INORGANIC MATERIAL. THE EDS SPECTRUM SHOWS THE PRESENCE OF CARBON (C), OXYGEN (O), SILICON (SI), SULPHUR (S), POTASSIUM (K) AND CALCIUM (CA). THE PARTICLE WAS ON THE OUTSIDE OF THE PAB UNIT AND WOULD NOT HAVE BEEN IN CONTACT WITH THE SOLUTION. PAB UNIT #2 PARTICLE 1- MEASURED 182UM AND WAS IDENTIFIED AS CELLULOSE (COTTON FIBER) AND INORGANIC MATERIAL. THE EDS SPECTRUM SHOWS THE PRESENCE OF CARBON (C), OXYGEN (O), SODIUM (NA), SILICON (SI), SULPHUR (S), CHLORINE (CL), POTASSIUM (K) AND CALCIUM (CA). THE PARTICLE WAS ON THE INSIDE OF THE PAB UNIT AND WOULD HAVE BEEN IN CONTACT WITH THE SOLUTION. PAB UNIT #3 PARTICLE 1: MEASURED 1.59MM AND WAS IDENTIFIED AS POLYPROPYLENE. THE PARTICLE WAS ON THE INSIDE OF THE PAB UNIT AND WOULD HAVE BEEN IN CONTACT WITH THE SOLUTION. PAB UNIT #4 PARTICLE 1- MEASURED 542UM AND WAS IDENTIFIED AS BENZOIC ACID AND INORGANIC MATERIAL. THE EDS SPECTRUM SHOWS THE PRESENCE OF CARBON (C), OXYGEN (O) AND ZINC (ZU). THE PARTICLE WAS EMBEDDED THE BAG MATERIAL OF THE PAB UNIT AND WOULD NOT HAVE BEEN IN CONTACT WITH THE SOLUTION. PAB UNIT #5 PARTICLE 1- MEASURED 587UM AND WAS IDENTIFIED AS BENZOIC ACID AND INORGANIC MATERIAL. THE EDS SPECTRUM SHOWS THE PRESENCE OF CARBON (C), OXYGEN (O), AND ZINC (ZN). THE PARTICLE WAS EMBEDDED IN THE BAG MATERIAL OF THE PAB UNIT AND WOULD NOT HAVE BEEN IN CONTACT WITH SOLUTION. A REVIEW OF OUR NON-CONFORMANCE SYSTEM DATABASE FOUND NO RELATED OR SIMILAR DISCREPANCIES DURING THE PRODUCTION OF THE BATCH. THE BATCH RECORD WAS ALSO REVIEWED, AND THE BATCH MET AND PASSED ALL RELEASE CRITERIA AND TESTS. ADDITIONALLY, VISUAL INSPECTION OF TWENTY (20) RETAIN UNITS PERFORMED BY A CERTIFIED INSPECTOR REVEALED THAT NO PARTICULATE MATTER BASED ON THE RESULTS OF THE INVESTIGATION, THE POSSIBLE SOURCE OF THE OBSERVED PM IN UNITS #1 AND #2 WAS EQUIPMENT USED IN MANUFACTURING. HUMAN ERROR ALSO CONTRIBUTED TO THE OBSERVED PM AS THE 100% PM INSPECTOR MAY HAVE NOT INSPECTED THE UNITS THOROUGHLY DUE TO ADDED TASKS. A PREVENTATIVE ACTION (RETRAINING) WAS PERFORMED IN ORDER TO MITIGATE THIS INCIDENT. REGARDING THE REMAINING UNITS, THE CONTAINERS USE FILM MATERIAL THAT IS MANUFACTURED BY A THIRD-PARTY VENDOR. AS A RESULT, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE VENDOR IN ORDER TO INVESTIGATE THE EMBEDDED PARTICLE ISSUE. VENDOR INVESTIGATION DETERMINED THAT THE SIZE OF THE PARTICLES WAS ACCEPTABLE AND CONFORMED TO SPECIFICATIONS. ADDITIONALLY, IT WAS DETERMINED THAT THE EMBEDDED PARTICLE DEFECT DID NOT IMPACT THE FUNCTION AND INTEGRITY OF THE MATERIAL PROVIDED TO B. BRAUN. THIS TYPE OF DEFECT IS CONSIDERED INHERENT TO THE MANUFACTURING PROCESS OF THE FILM AND IS CONSIDERED TO BE A COSMETIC DEFECT. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: DURING 100% VISUAL INSPECTION OF COMPOUNDED LOT # J4N717, TWO (2) BAGS WERE FOUND WITH ONE (1) FOREIGN PARTICULATE IN EACH. NO INJUSRY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918071 PAB® CONTAINER, I.V. KPE B. BRAUN MEDICAL INC - IRVINE J4N717 04046964187698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown