BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJCT 60ML SYR L-LOCK BNS

    MDR report key: 12935054 · Received December 6, 2021

    Report

    Report Number
    1915484-2021-01265
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 30, 2021
    Report Date
    February 7, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMF
    UDI-DI
    10884521010963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEFINITIVE LOT NUMBER COULD NOT BE DETERMINED, BUT IT IS EITHER 916879X OR 011187X.THE DEVICE HISTORY RECORD OF THE TWO PROVIDED LOT NUMBERS WERE REVIEWED SHOWING PIECES WERE VISUALLY INSPECTED AND PHYSICALLY TESTED WITH NO ISSUES RELATING TO THE REPORTED CONDITION. NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE MANUFACTURING SITE WAS PROVIDED ONE REPRESENTATIVE PHOTOGRAPH FOR ANALYSIS. IN THE PHOTOGRAPH PROVIDED, THE LENGTH OF A 60 ML MONOJECT SYRINGE CAN BE OBSERVED. THE SYRINGE TIP APPEARS TO BE SLIGHTLY SLANTED. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BY REVIEWING THE PROVIDED PHOTOGRAPH. CONTROL MECHANISMS ARE IN PLACE TO PREVENT THE OCCURRENCE AND ACCEPTANCE OF THE REPORTED CONDITION DURING MOLDING, PRINTING, ASSEMBLY, AND PACKAGING PROCESSES, AND TO ENSURE COMPONENTS AND FINISHED PRODUCT MEET ALL QUALITY INSPECTION STANDARDS (QIS) DURING THE SYRINGE ASSEMBLY PROCESSES. A MATERIAL VERIFICATION PROCESSES IS MAINTAINED AT THE MANUFACTURING SITE. THE RAW MATERIALS MUST PASS AN INSPECTION AND CERTIFICATION REVIEW BEFORE RELEASE TO THE FLOOR FOR PRODUCTION. THE CRITICAL DIMENSIONS OF THE MOLDED COMPONENTS ARE GAUGED TO ENSURE MOLDED COMPONENTS MEET DIMENSIONAL SPECIFICATIONS AND ARE VISUALLY AND PHYSICALLY TESTED FOR ADHERENCE TO THE QIS. MOLDING, PRINTING, ASSEMBLY, AND PACKAGING MACHINE MAINTENANCE REQUIREMENTS ARE DOCUMENTED. PERSONNEL ARE TRAINED AND CERTIFIED IN THE OPERATION OF THE MOLDING, PRINTING, ASSEMBLY, AND PACKAGING EQUIPMENT. DURING MANUFACTURING, PROCESS INSPECTORS INSPECT PRODUCT AT PERIODIC INTERVALS TO ENSURE IT MEETS ACCEPTABLE QUALITY LIMITS (AQL). PROCEDURES AND STANDARD WORK INSTRUCTIONS EXIST FOR THE SET-UP, OPERATION, AND MAINTENANCE OF THE MOLDING MACHINES AND ASSEMBLY MACHINES. CLEANING AND MAINTENANCE REQUIREMENTS ARE DEFINED AND IMPLEMENTED TO ENSURE CONTINUING PROCESS CAPABILITY. ALL LOTS AND SHOP ORDERS ARE VISUALLY AND PHYSICALLY INSPECTED TO THE QIS AND THE STATISTICAL SAMPLING MUST MEET THE AQL REQUIREMENTS DURING THE MOLDING AND ASSEMBLY PROCESS. PER PROCEDURE, COMPLAINT TRENDS ARE EVALUATED DURING THE MONTHLY CORRECTIVE AND PREVENTATIVE ACTION (CAPA) MEETING TO DETERMINE IF A CAPA IS WARRANTED. AT THIS TIME, A CAPA WILL NOT BE INITIATED. HOWEVER, THESE CONDITIONS WILL BE COMMUNICATED TO THE APPROPRIATE MANUFACTURING AND QUALITY ASSURANCE PERSONNEL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ONE SYRINGE HAD A SKEWED/SLANTED TIP AND THREADS. THE DEFINITIVE LOT NUMBER COULD NOT BE DETERMINED, BUT IT IS EITHER 916879X OR 011187X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830229 MONOJCT 60ML SYR L-LOCK BNS SYRINGE, PISTON FMF CARDINAL HEALTH 8881160629 10884521010963

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown