BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLATOR SYRINGE

    MDR report key: 6120439 · Received November 22, 2016

    Report

    Report Number
    2523676-2016-00814
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    June 30, 2016
    Report Date
    July 4, 2016
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    DXT
    UDI-DI
    04022495172532
    PMA / PMN Number
    K902377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). ONE USED INFLATOR SYRINGE, WITHOUT PACKAGING, WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS SUBJECTED SYRINGE PRESSURE TESTING ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. DURING THIS TESTING, THERE WERE NO LEAKAGES OBSERVED AND THERE WERE NO ISSUES NOTED DURING INFLATION. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE RETURNED SAMPLE MET REQUIREMENTS ACCORDING TO SPECIFICATION, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. NOTE: THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. B. BRAUN HAS CONDUCTED A RETROSPECTIVE REVIEW FOR ALL COMPLAINTS OF A SIMILAR NATURE IN ACCORDANCE WITH INTERNAL PROCEDURE COP-QP-8000051.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE SURGEON TRIED TO EXPAND THE BALLOON CATHETER DURING PTA SURGERY, HOWEVER IT WOULD NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770644 INFLATOR SYRINGE INJECTOR AND SYRINGE, ANGIO DXT B. BRAUN MEDICAL INC. 0061440959 04022495172532

    Patients

    Seq Age Sex Outcome Treatment
    1