BEUDAMED
    FDA Adverse Event Injury Summary report: N

    90 ML PREFILLED PJ

    MDR report key: 7526550 · Received May 18, 2018

    Report

    Report Number
    1419341-2018-00001
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    April 13, 2018
    Report Date
    January 2, 2019
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND
    Product Code
    IFP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ACTIONS AND TIMELINE: A SUPPLIER CORRECTIVE ACTION (SCAR 38) WAS ISSUED TO THE SUPPLIER OF THE JARS USED IN THE MANUFACTURE OF THE IMPACTED PRODUCT (PART NUMBER 3800780). THIS SCAR WAS ISSUED BASED ON PRELIMINARY FINDINGS THAT INADEQUATE SEALING OF THE JAR PACKAGING WAS CONTRIBUTING TO PRODUCT LEAKING DURING TRANSIT. DUE TO THE INABILITY OF THE SUPPLIER TO RESOLVE THE ISSUE WITH THEIR CURRENT JAR DESIGN, A NEW JAR SUPPLIER WAS QUALIFIED UNDER CAPA 2018-006, AND JARS FROM THE ORIGINAL SUPPLIER WERE DISCONTINUED ON (B)(6) 2018. ROOT CAUSE: JAR PACKAGING FROM THE ORIGINAL SUPPLIER WAS NOT ADEQUATELY SEALING TO PREVENT LEAKING DURING TRANSIT. CORRECTIVE ACTION: CAPA 2018-006 DOCUMENTS THE QUALIFICATION OF A NEW JAR SUPPLIER FOR PART NUMBER 3800780. BASED ON A REVIEW OF COMPLAINTS SINCE THE IMPLEMENTATION OF THE NEW JARS FROM THIS SUPPLIER AND DISCONTINUING THE ORIGINAL SUPPLIER ON 12/03/2018, ZERO REPORTED COMPLAINTS HAVE BEEN RECEIVED FOR LEAKING OF PART NUMBER 3800780, INDICATING THE EFFECTIVENESS OF THE CORRECTIVE ACTIONS TAKEN.

    Description of Event or Problem · 0

    ON (B)(6), 2018, PRODUCT WAS RECEIVED BY CUSTOMER MATERIALS MANAGEMENT DEPARTMENT AND ARRIVED LEAKING AND DAMAGED. OUTER CASE PACKAGING WAS REPORTED TO BE DRY WHILE THE INNER CASE PACKAGING WAS REPORTED TO BE WET FROM LEAKAGE. CUSTOMER EMPLOYEE WHO OPENED THE OUTER CASE PACKAGING WAS EXPOSED TO FORMALIN FUMES AND SOUGHT MEDICAL ATTENTION FOR RESPIRATORY PROBLEMS. NO FOLLOW UP MEDICAL ATTENTION WAS REQUIRED, EMPLOYEE WAS RELEASED THE SAME DAY. PRODUCT WAS DISPOSED OF BY THE CARRIER.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2018, PRODUCT WAS RECEIVED BY CUSTOMER MATERIALS MANAGEMENT DEPARTMENT AND ARRIVED LEAKING AND DAMAGED. OUTER CASE PACKAGING WAS REPORTED TO BE DRY WHILE THE INNER CASE PACKAGING WAS REPORTED TO BE WET FROM LEAKAGE. CUSTOMER EMPLOYEE WHO OPENED THE OUTER CASE PACKAGING WAS EXPOSED TO FORMALIN FUMES AND SOUGHT MEDICAL ATTENTION FOR RESPIRATORY PROBLEMS. NO FOLLOW UP MEDICAL ATTENTION WAS REQUIRED, EMPLOYEE WAS RELEASED THE SAME DAY. PRODUCT WAS DISPOSED BY THE CARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367894 90 ML PREFILLED PJ 90 ML PREFILLED PJS IFP LEICA BIOSYSTEMS RICHMOND 3800780 022720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other