BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LOCKING SYRINGE

    MDR report key: 17148475 · Received June 16, 2023

    Report

    Report Number
    2015691-2023-13978
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 25, 2023
    Report Date
    November 14, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE EDWARDS LOCKING SYRINGE COMMERCIALIZED IN EUROPE BY EDWARDS LIFESCIENCES IS SIMILAR TO THE MARKETED DEVICE IN THE UNITED STATES BY ATRION MEDICAL PRODUCTS, INC. UNDER 510K (K060643).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND AN ENGINEERING EVALUATION WAS PERFORMED. THE RETURNED DEVICE WAS VISUALLY EXAMINED FOR ANY ABNORMALITIES AND THE FOLLOWING WAS OBSERVED: BLACK PARTICULATES WITHIN ATRION INFLATION DEVICE. ATRION SUPPLIER PERFORMED EVALUATION AND THE FOLLOWING OBSERVED: BLACK SUBSTANCE WAS NOTED ALONG THE INSIDE OF THE HOUSING. INNER PART OF THE HOUSING EXHIBITS AN UNKNOWN CRYSTALIZED SUBSTANCE. DELAMINATION ALONG THE INSIDE OF THE QUAD RING. NOTE: THE QUAD RING PASSED THE HARDNESS TEST (SHORE A) AND THE NOTED DELAMINATION COULD BE RELATED TO A CHEMICAL REACTION. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE COMPLAINT OF PARTICULATE WAS CONFIRMED BASED ON IMAGERY AND RETURNED DEVICE PROVIDED FOR EVALUATION. A REVIEW OF THE DHR, LOT HISTORY, COMPLAINT HISTORY, AND MANUFACTURING MITIGATION DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. AS REPORTED, ''DURING DEVICE PREPARATION BLACK DEPOSITS WERE FOUND ON THE INNER SURFACE OF THE 38 ML EDWARDS LOCKING SYRINGE WHILE FILLING WITH CONTRAST''. PER SUPPLIER INVESTIGATION, FTIR MATERIAL ANALYSIS WAS PERFORMED ON THE BLACK PARTICULATE AND THE TEST WAS INCONCLUSIVE. ATRION WAS UNABLE TO REPLICATE THE SUBSTANCE WITHIN NORMAL OPERATING PARAMETERS AND WITHOUT VISIBLY DAMAGING THE QUAD RING. THERE ARE ALSO MULTIPLE MITIGATIONS SUCH AS REGULAR CYCLING OF THE DEVICE TO ENSURE SMOOTH OPERATION AND FINISHED GOOD INSPECTIONS BEFORE THE DEVICE IS PACKAGED FOR SHIPMENT. THEREFORE, THIS EVENT IS CONSIDERED AN INCONCLUSIVE ISOLATED EVENT. AS THE SOURCE OF CONTAMINATION REMAINS UNKNOWN, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. THEREFORE, NO FURTHER ESCALATION (CAPA/SCAR/PRA) IS REQUIRED . HOWEVER, AN AWARENESS COMMUNICATION WAS PERFORMED BY THE SUPPLIER AS A PRECAUTIONARY MEASURE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE CORRECTION: ADDED H6: TYPE OF INVESTIGATION CODE.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION FROM OUR AFFILIATE IN GERMANY. AS REPORTED, DURING DEVICE PREPARATION, BLACK DEPOSITS WERE FOUND ON THE INNER SURFACE OF THE 38 ML EDWARDS LOCKING SYRINGE WHILE FILLING WITH CONTRAST. A NEW ATRION INFLATION DEVICE WAS USED FOR THE PROCEDURE. THE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527747 EDWARDS LOCKING SYRINGE SYRINGE, BALLOON INFLATION MAV EDWARDS LIFESCIENCES 96406 96406158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown