BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION SET

    MDR report key: 10592463 · Received September 28, 2020

    Report

    Report Number
    2523676-2020-00271
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Report Date
    November 30, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    LJH
    UDI-DI
    04046964175794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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). TWO (2) PHOTOS WERE PROVIDED FOR EVALUATION. UPON VISUAL INSPECTION OF THE PHOTOS, IT WAS NOTED THAT THE FIRST PHOTO DEPICTED A SPIKE THAT WAS NOT LISTED ON THE DRAWING FOR THE REPORTED ITEM NUMBER. THE SECOND PHOTO WAS VISUALLY INSPECTED WITH PASSING RESULTS, AS NO DEFECTS WERE NOTED. AS THE ITEM PICTURED IS DIFFERENT THAN THE REPORTED ITEM NUMBER, THE EXACT ROOT CAUSE OF THE REPORTED DEFECT COULD NOT BE DETERMINED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF 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). 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: IT WAS REPORTED THAT WHEN ASSESSING THE PATIENT AND CBI THE RN NOTICED THAT THERE WAS SOMETHING IN THE TUBING, WHEN SHE PINCHED IT SHE REALIZED IT WAS HARD, NOT SEDIMENT. THE CBI WAS STOPPED, TUBING DISCONNECTED, AND FLUSHED. THE PARTICLE OF PLASTIC WAS THE TIP OFF THE SPIKE. NEW TUBING WAS USED TO CONTINUE CBI. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056818 IRRIGATION SET SYSTEM, IRRIGATION, UROLOG LJH B. BRAUN MEDICAL INC. 313003 04046964175794

    Patients

    Seq Age Sex Outcome Treatment
    1