BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPO NEEDLE 25G X 1 A BEV RP

    MDR report key: 8482946 · Received April 4, 2019

    Report

    Report Number
    1017768-2019-00613
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    January 31, 2019
    Report Date
    August 5, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBERS 832324 INDICATES THAT THERE WERE NO DEFECTS FOUND IN ANY OF THE SAMPLES INSPECTED FROM THE LOT. THERE WERE THIRTEEN OPENED SAMPLES RETURNED WITH THIS COMPLAINT. THE SAMPLES WERE VISUALLY INSPECTED, AND CONTAMINATION WAS OBSERVED ON THE CANNULA. THE REPORTED CONDITION IS CONFIRMED. A LABORATORY REPORT WAS SENT WITH THE SAMPLES. THE REPORT IDENTIFIED THE CONTAMINATION AS POLYPROPYLENE, POLYESTER URETHANE, ORGANIC COMPOUND, CELLULOSE FIBER, PTFE, FIBER OF UNDETERMINED ORIGIN, AND SILICONE. THE MOST LIKELY ROOT CAUSE OF THE PRESENCE OF POLYPROPYLENE IS THAT A SMALL PIECE OF PLASTIC WAS DISLODGED FROM THE COMPONENT. ALL OF THE PLASTIC COMPONENTS OF THE NEEDLE ARE POLYPROPYLENE. THE MOST LIKELY ROOT CAUSE FOR THE PRESENCE OF POLYESTER URETHANE, MAY HAVE ORIGINATED FROM MANUFACTURING EQUIPMENT THAT IS COATED WITH POLYESTER URETHANE. THE MOST LIKELY ROOT CAUSE FOR THE ORGANIC COMPOUND IS UNKNOWN. THE MOST LIKELY ROOT CAUSE OF THE PRESENCE OF CELLULOSE FIBER IS THE WRAP USED ON THE CANNULA. THERE IS A PAPER WRAPPING ON THE BUNDLES OF CANNULA. THE MOST LIKELY ROOT CAUSE FOR THE PRESENCE OF THE PTFE IS THAT WHITE PTFE TAPE IS USED ON THREADS OF FITTINGS FOR SEALING PURPOSES. IT IS POSSIBLE A SMALL PIECE OF TAPE BECAME AIRBORNE AND ATTACHED TO THE CANNULA. THE MOST LIKELY ROOT CAUSE OF THE FIBER OF UNKNOWN ORIGIN- IS UNKNOWN. OPERATORS WEAR HAIRNETS AND BEARD GUARDS, IF NEEDED, IN PRODUCTION. THE MOST LIKELY ROOT CAUSE OF THE PRESENCE OF SILICONE IS THE SILICONE LUBRICANT THAT COATS THE OUTER DIAMETER OF THE CANNULA. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE TAKEN THROUGHOUT THE PRODUCTION OF THE LOT A CHECKED FOR CONTAMINATION. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. CORRECTIVE ACTIONS BEING TAKEN ARE TO DOCUMENT AND CONTROL THE VALIDATION AND SOFTWARE SYSTEMS AS WELL AS INCREASING THE INSPECTION PROCESS TO 100% INSPECTION FOR PARTICULATE ON THE CANNULA. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR ADDITIONAL CORRECTIVE ACTIONS.

    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. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THERE WERE DEPOSITS/FOREIGN PARTICLES ON THE STAINLESS STEEL TUBE OF STERILE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275928 HYPO NEEDLE 25G X 1 A BEV RP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881250305 832324

    Patients

    Seq Age Sex Outcome Treatment
    1