BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAB

    MDR report key: 9853158 · Received March 19, 2020

    Report

    Report Number
    2021236-2020-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 13, 2020
    Report Date
    May 20, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). NO SAMPLES WERE RETURNED IN CONJUNCTION WITH THIS COMPLAINT, AND A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. VISUAL INSPECTION ON TWO (2) RETAINED UNITS REVEALED THAT NO PARTICULATE MATTER WAS OBSERVED IN ANY OF THE RETAINED UNITS. THE BATCH RECORD WAS REVIEWED AND THE BATCH MET AND PASSED ALL RELEASE CRITERIA AND TESTS. A REVIEW OF OUR DISCREPANCY MANAGEMENT SYSTEM DATABASE FOUND NO RELATED OR SIMILAR DISCREPANCIES DURING THE PRODUCTION OF THE BATCH. IN RESPONSE TO HIGH LEVELS OF PARTICULATE MATTER (PM), PLASTIC RESIDUE, ON THE PAB ASSEMBLY EQUIPMENT, SOP-1001619 PAB BAG ASSEMBLY MACHINE CLEANING CHECKSHEET WAS REVISED TO INCREASE THE FREQUENCY OF MACHINE CLEANING. REVISION 8.0 WAS APPROVED ON (B)(6) 2019. BATCH J8J710 WAS MANUFACTURED PRIOR TO THE REVISION OF THE PROCEDURE. THE ASSEMBLY EQUIPMENT TECHNICIANS HAVE ALSO BEEN RETRAINED TO SOP-PH-1003059, VERSION 17.0, PAB ASSEMBLY TECHNICIAN STANDARDIZED PROCEDURES. B. BRAUN WILL CONTINUE TO INVESTIGATE, TREND, AND MONITOR ALL COMPLAINTS OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. 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 · 1

    AS REPORTED BY THE USER FACILITY: WHILE MAKING AN IV SOLUTION WITHIN AN EMPTY BAG, A PARTICLE WAS NOTICED IN THE SOLUTION. THE PARTICLE APPEARED TO BE A PART OF THE BAG THAT HAD SOMEHOW BECOME DISLODGED OR BROKEN OFF DURING MANIPULATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321330 PAB CONTAINER, IV KPE B. BRAUN MEDICAL INC J8J710 04046964187698

    Patients

    Seq Age Sex Outcome Treatment
    1