BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEEDLES AND SYRINGES

    MDR report key: 10017575 · Received May 1, 2020

    Report

    Report Number
    1915484-2020-01164
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 17, 2020
    Report Date
    July 13, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: WITHOUT A KNOWN LOT NUMBER, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE MANUFACTURING SITE HAS NOT RECEIVED A SAMPLE FOR FURTHER EVALUATION. ONE PICTURE WAS SUPPLIED BY THE CUSTOMER SHOWING THAT THE TIP IS NO LONGER PRESENT, AND IT APPEARS THE LUER THREADS MAY BE STRIPPED. WITHOUT A REPRESENTATIVE SAMPLE OR MORE PICTURE BEING PROVIDED, A MORE COMPLETE INVESTIGATION CANNOT BE PERFORMED TO THE FULL EXTENT AND THE ROOT CAUSE COULD NOT BE DETERMINED. 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, PRINTED, ASSEMBLED, AND PACKAGED PRODUCT 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 MOLDED COMPONENTS ARE VISUALLY AND PHYSICALLY TESTED FOR ADHERENCE TO THE QUALITY INSPECTION STANDARD (QIS). PERSONNEL ARE TRAINED AND CERTIFIED IN THE OPERATION OF THE MOLDING, ASSEMBLY AND PACKAGING EQUIPMENT, AND PRODUCT EVALUATION AND DOCUMENTATION REQUIREMENTS. 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. PROCESS INSPECTORS ARE REQUIRED TO CONDUCT VISUAL AND PHYSICAL EVALUATIONS OF THE PRODUCT AND PACKAGING, TO THE QIS, AT PRESCRIBED INTERVALS DURING THE MANUFACTURE OF ALL LOTS AND SHOP ORDERS, AND CANNOT RELEASE PRODUCT UNLESS THE REQUIRED ACCEPTABLE QUALITY LEVEL (AQL) HAS BEEN MET PER THE SPECIFICATION. A LOT CANNOT BE RELEASED UNLESS IT PASSES SPECIFICATION REQUIREMENTS. COMPLAINT TRENDS ARE EVALUATED DURING THE MONTHLY CORRECTIVE AND PREVENTATIVE ACTION (CAPA) MEETING TO DETERMINE IF A CAPA IS WARRANTED. BASED ON THE INFORMATION AVAILABLE AND THE INVESTIGATION FINDINGS, A CAPA IS NOT DEEMED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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.  IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A MONOJECT 35 ML SYRINGE WITH AN UNKNOWN PRODUCT ID AND LOT NUMBER WAS BEING FILLED BY THEIR ONSITE PHARMACY AND UPON USE, THEY FOUND THE TIP HAD BROKEN OFF. THE CUSTOMER FURTHER STATED THAT THIS ISSUE IS CAUSING THE HOSPITAL TO WASTE QUITE A BIT OF FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481661 UNKNOWN NEEDLES AND SYRINGES SYRINGE, PISTON FMF COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1