BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 3782226 · Received April 30, 2014

    Report

    Report Number
    9610902-2014-00006
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    March 31, 2014
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Removal / Correction Number
    1925223-04/23/14-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. THE DEVICE WAS USED UP AND NOT AVAILABLE FOR RETURN. RETAINED SAMPLES OF SAME LOT TESTED. TESTED THE EXTRUSION PERFORMANCE OF THE SYRINGES. VISUALLY EXAMINED THE EXTRUDED MATERIAL. EXTRUSION PERFORMANCE NOT AS EXPECTED. CHANGES TO SYRINGE WERE IMPLEMENTED. THE LOW END OF THE VISCOSITY RANGE APPEARS TO BE INCOMPATIBLE WITH THIS NEW SYRINGE DESIGN. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. (B)(4).

    Description of Event or Problem · 1

    WHEN STARTING TO PUSH MATERIAL OUT OF A NEW GDPG SYRINGE IT HAPPENS THAT YOU FEEL SOME RESISTANCE AND THEN SUDDENLY A LARGER AMOUNT OF MATERIAL "BLOBS" OUT IN AN UNCONTROLLED WAY. THIS PHENOMENON IS MORE AND MORE OFTEN NOTICED AND OCCURS ONLY WITH NEW SYRINGES. TILL NOW NO PATIENT HAS BEEN HARMED BUT WE SHOULD LOOK INTO THIS BEFORE SERIOUS INCIDENTS HAPPEN. WE HAVE NO MATERIAL AVAILABLE THAT WE CAN SEND BACK. AS MENTIONED, IF THE "BLOBBING" OCCURS, THIS IS ONLY WITH THE 1ST USE OF A NEW SYRINGE. WITH THE 2ND USE THERE ARE NO PROBLEMS.

    Description of Event or Problem · 1

    WHEN STARTING TO PUSH MATERIAL OUT OF A NEW GDPG SYRINGE IT HAPPENS THAT YOU FEEL SOME RESISTANCE AND THEN SUDDENLY A LARGER AMOUNT OF MATERIAL "BLOBS" OUT IN AN UNCONTROLLED WAY. THIS PHENOMENON IS MORE AND MORE OFTEN NOTICED AND OCCURS ONLY WITH NEW SYRINGES. TILL NOW NO PATIENT HAS BEEN HARMED BUT WE SHOULD LOOK INTO THIS BEFORE SERIOUS INCIDENTS HAPPEN. WE HAVE NO MATERIAL AVAILABLE THAT WE CAN SEND BACK. AS MENTIONED, IF THE "BLOBBING" OCCURS, THIS IS ONLY WITH THE 1ST USE OF A NEW SYRINGE. WITH THE 2ND USE THERE ARE NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259763 GLUMA DESENSITIZER POWERGEL VARNISH LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1