BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35ML SYRINGE LUER LOCK TIP RP

    MDR report key: 12094724 · Received June 30, 2021

    Report

    Report Number
    1915484-2021-01260
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 13, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    UDI-DI
    20884521012193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE MANUFACTURING SITE RECEIVED TWO UNSEALED PACKAGE SAMPLES WITH THIS CUSTOMER REPORT. A COMPLETE INVESTIGATION WAS PERFORMED. VISUAL INSPECTION TO THE QUALITY INSPECTION STANDARD (QIS) WAS CONDUCTED. LOW TOP LINE WAS IDENTIFIED ON ONE OF THE SYRINGE SAMPLES RECEIVED. ON THE SYRINGE IDENTIFIED WITH A LOW TOP LINE, THERE WAS ALSO DAMAGE TO THE BARREL THUMB REST. THE SECOND SAMPLE HAD ZERO ISSUES. THE MOST PROBABLE ROOT CAUSE FOR THE LOW TOP LINE BARREL PRINT IS A RESULT OF THE DAMAGE TO THE BASE OF THE BARREL. IT IS LIKELY THE BARREL WAS NOT ABLE TO BE FULLY SEATED PROPERLY ON THE PIN AT THE BARREL PRINT STATION CAUSING THE PRINT TO BE APPLIED LOWER ON THE BARREL. THE MOST PROBABLE ROOT CAUSE FOR THE DAMAGED BARREL IS THE PART BEING CAUGHT DURING TRANSFER WITHIN THE ASSEMBLY PROCESS. THE FOLLOWING 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 QISS DURING THE SYRINGE ASSEMBLY PROCESSES. THE MANUFACTURING SITE MAINTAINS A MATERIAL VERIFICATION PROCESSES. THE RAW MATERIALS MUST PASS AN INSPECTION AND CERTIFICATION REVIEW BEFORE RELEASE TO THE FLOOR FOR PRODUCTION. THE MANUFACTURE OF ALL MOLDED COMPONENTS IS CONDUCTED WITHIN A VALIDATED PROCESS INSIDE A CONTROLLED MANUFACTURING AREA. 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. IF PROBLEMS WERE DETECTED DURING PROCESSING, NON-CONFORMING PRODUCT WOULD BE IDENTIFIED AND SEGREGATED. MOLDING, PRINTING, ASSEMBLY, AND PACKAGING MACHINE MAINTENANCE REQUIREMENTS ARE DOCUMENTED. RECORDS OF MAINTENANCE ACTIVITIES ARE MAINTAINED. PERSONNEL ARE TRAINED AND CERTIFIED IN THE OPERATION OF THE MOLDING, PRINTING, ASSEMBLY, AND PACKAGING EQUIPMENT. PERSONNEL ARE TRAINED AND CERTIFIED IN THE PROCESS OF PRODUCT EVALUATION AND DOCUMENTATION REQUIREMENTS. DURING THE MANUFACTURING, PROCESS INSPECTORS INSPECT PRODUCT AT PERIODIC INTERVALS TO ENSURE IT MEETS ACCEPTABLE QUALITY LIMITS (AQL). PROCESS INSPECTORS ARE REQUIRED TO CONDUCT VISUAL AND PHYSICAL EVALUATIONS AT PRESCRIBED INTERVALS AND CANNOT RELEASE PRODUCT UNLESS THE REQUIRED AQL HAS BEEN MET PER THE SPECIFICATION. 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. OPERATORS ARE INSTRUCTED TO INSPECT ALL PRODUCT USED FOR REGRINDING ACTIVITIES FOR POTENTIAL CONTAMINANTS SUCH AS COLOR, RUBBER TIPS, CANNULA, OR INCLUSIONS TO ASSURE IT IS CLEAN BEFORE REGRINDING. A LOT CANNOT BE RELEASED UNLESS IT PASSES SPECIFICATION REQUIREMENTS. 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. A QUALITY ALERT WILL BE DISTRIBUTED TO NECESSARY PRODUCTION AND QUALITY PERSONNEL TO HEIGHTEN AWARENESS TO THE CONFIRMED REPORTED CONDITION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MARKINGS ON THE SYRINGE ARE WRONG AND POTENTIALLY RESULTING IN A DRAW UP OF MORE FLUID THAN NEEDED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987046 35ML SYRINGE LUER LOCK TIP RP SYRINGE, PISTON FMF COVIDIEN 8881535762 20884521012193

    Patients

    Seq Age Sex Outcome Treatment
    1