BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH LAB TRAY

    MDR report key: 3941124 · Received April 25, 2014

    Report

    Report Number
    3005011024-2014-00003
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 25, 2014
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE WORK ORDER WAS REVIEWED TO OBTAIN THE RAW MATERIAL AND RAW MATERIAL LOT NUMBER IN REFERENCE TO THE REPORT. RAW MATERIAL 5-20055, LOT NUMBER 13-7969-1, WAS IDENTIFIED. THE 2012, 2013, AND 2014 SCAR LOGS WERE REVIEWED TO IDENTIFY SIMILAR REPORTS. A SIMILAR REPORT WAS IDENTIFIED IN 2014. SCAR2014-181KJG HAS BEEN ISSUED TO INTERNATIONAL MEDSURG. THE SCAR DUE DATE HAS BEEN IDENTIFIED AS (B)(6) 2014. THE VENDOR HAS SUPPLIED THE RESPONSE TO THE SCAR DUE TO THE IDENTIFIED LOT NUMBER BEING THE SAME AS A PREVIOUS REPORT. REFER TO THE SCAR2014-181KJG CALL (B)(4) ATTACHMENT. THE QC COMPLAINT SPECIALIST HAS REQUESTED INFORMATION AS TO THE FIRST LOT NUMBER PRODUCED AFTER THE IDENTIFIED CORRECTIVE ACTIONS WERE IMPLEMENTED. APRIL 07, 2014 THE REQUESTED INFORMATION HAS BEEN PROVIDED AND THE VENDOR IDENTIFIED THE FIRST REPORTED LOT NUMBER AS 14-8593-1 (B)(4) WITH AN APPROXIMATE SHIP DATE OF (B)(4) 2014. CORRECTION: A CORRECTION HAS NOT BEEN TAKEN. ROOT CAUSE ANALYSIS: SCAR: BASED ON THE DEFECTIVE SAMPLES RECEIVED, IT WAS DETERMINED THE SUBSTANCE WAS THE BLACK INK THAT IS USED TO PRINT THE NUMBERS AND GRADUATIONS ON TO THE SYRINGE. THE INK FROM THE SILK SCREEN INK RESIDUE WAS THE ROOT CAUSE OF THE DEFECT.

    Description of Event or Problem · 1

    THE CUSTOMER OPENED A CATH TRAY AND SOMEONE NOTICED A BLACK COLORED RESIDUE ON ONE OF THE SYRINGES. WHEN THEY DISCONNECTED FROM THE CATH THEY HAD JUST FLUSHED IT ALSO HAD BLACK DISCOLORATION AT THE HUB OF THE CATHETER. BOTH WERE TAKEN OUT OF USE AND BROUGHT TO ME. THE TRASH BAG WITH THE LOT NUMBER HAD ALREADY BEEN DISCARDED; HOWEVER, THE CURRENT LOT NUMBER ON THE PACKS IN THE ROOMS IS LOT NUMBER 34983404. THE CATHETER AND THE SYRINGE WERE SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250719 CATH LAB TRAY KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES 34983404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention