BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD ADMINISTRATION SET

    MDR report key: 8883044 · Received August 12, 2019

    Report

    Report Number
    9614279-2019-00117
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 22, 2019
    Manufacturer
    B. BRAUN DOMINICIAN REPULIC INC.
    Product Code
    FPA
    UDI-DI
    04046964187483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ALTHOUGH NO SAMPLE WAS PROVIDED FOR FURTHER EVALUATION, ALL AVAILABLE INFORMATION WAS FORWARDED TO OUR SUPPLIER FOR FURTHER EVALUATION. BASED ON THE SUPPLIER'S STATEMENT, THE SUPPLIER REVIEWED THEIR MANUFACTURING PROCESS AND WERE ABLE TO OBSERVE INCONSISTENCIES DURING THE ASSEMBLE PROCESS. IT WAS DETERMINED THAT THE ISSUE OF LEAKING IS DUE TO INSUFFICIENT GLUE WHEN ADHERING THE MOLDED ENDS TO THE TUBE. THE SUPPLIER IS CURRENTLY GENERATING NEW VISUAL PICTURES AND WRITTEN INSTRUCTIONS TO AID DURING THE ASSEMBLY PROCESS. ALL OPERATORS INVOLVED WITH THE ASSEMBLY PROCESS WILL BE TRAINED TO THESE NEW PROCEDURES. WE WILL MAINTAIN THIS REPORT FOR FUTURE REFERENCE, AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. IN ADDITION, REVIEW OF THE BATCH HISTORY RECORDS WAS ALSO PERFORMED FOR THE REPORTED LOT NUMBER AND NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED DURING THE MANUFACTURING PROCESS OR FINAL INSPECTIONS. 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 · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ALTHOUGH IT WAS CONFIRMED THAT THE DEVICE INVOLVED IS NOT AVAILABLE FOR EVALUATION, 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: EVENT 1: CUSTOMER REPORTED TWO DIFFERENT ISSUES WITH THE BLOOD TUBING LEAKING FROM ONE SIDE OR THE OTHER. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679290 BLOOD ADMINISTRATION SET SET, ADMINISTRATION, INTRA FPA B. BRAUN DOMINICIAN REPULIC INC. 0061681745 04046964187483

    Patients

    Seq Age Sex Outcome Treatment
    1