BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC LL SYRINGE P-LK O/P

    MDR report key: 5775849 · Received July 7, 2016

    Report

    Report Number
    1017768-2016-00042
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Report Date
    June 22, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 07/07/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES. ALL SPRAYMATION PARAMETERS WERE WITHIN VALIDATED RANGES THROUGHOUT PRODUCTION OF THE LOT. ADDITIONALLY, NO NCRS WERE ASSIGNED TO THIS LOT. THERE WERE 3 OPENED SAMPLES SUBMITTED WITH THIS COMPLAINT. THE SAMPLES WERE VISUALLY INSPECTED BY THE QUALITY ENGINEER AND THE REPORTED CONDITION WAS CONFIRMED. THE SAMPLES WERE ALSO ANALYZED BY TECHNICIANS AT THE LAB IN (B)(4). THEY PERFORMED FTIR TESTING ON THE PARTICULATE MATTER AND DETERMINED THE MATERIAL IDENTITY OF THE STRING-LIKE FIBER TO BE POLYPROPYLENE AND THE SQUARE-LIKE MATTER TO BE SILICONE. THEIR ASSESSMENT IS DOCUMENTED IN (B)(4). THE REPORTED CONDITION IS CONFIRMED. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. LABORATORY ANALYSIS OF THE SAMPLES IDENTIFIED THE STRING-LIKE CONTAMINANT TO BE POLYPROPYLENE, WHICH IS A PARENTAL MATERIAL FOR THE SYRINGE. SEVERAL CONTRIBUTING FACTORS WERE ASSESSED AND THE MOST LIKELY ROOT CAUSES WERE RELATED TO THE DEFICIENCIES IN THE CLEANING PROCESS AND ENVIRONMENTAL CONTAMINATION OF THE RUBBER TIPS WHILE CONVEYING IN THE RUBBER TIP TRACKS. SQUARE-SHAPED MATTER (SOLIDIFIED SILICONE): LABORATORY ANALYSIS OF THE SAMPLES DETERMINED THE SQUARE-LIKE MATTER TO BE SILICONE. DURING THE MANUFACTURING PROCESS, LIQUID SILICONE IS INTENTIONALLY SPRAYED IN THE BARRELS OF SYRINGES AS A LUBRICANT FOR THE PLUNGER. THE INVESTIGATION WAS UNABLE TO DETERMINE EXACTLY HOW THE SILICONE COULD HAVE CHANGED FROM A LIQUID STATE TO A SOLID STATE. THE EXACT ROOT CAUSE FOR THE PRESENCE OF SOLIDIFIED SILICONE COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. 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 VISUALLY INSPECTED FOR EXCESSIVE LUBRICANT IN THE SYRINGE AND PARTICULATE IN THE FLUID PATHWAY. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. BASED ON THE FINDINGS OF THE ROOT CAUSE INVESTIGATION FOR THE POLYPROPYLENE FIBER, THE FOLLOWING ACTIONS WILL BE TAKEN. FORMAL WORK AND CHANGE ORDERS WERE IMPLEMENTED IN REGARDS TO THIS ISSUE. NO CORRECTIVE ACTIONS WERE TAKEN FOR THE SOLID SILICONE PIECE INSIDE THE SYRINGE BECAUSE A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON AVAILABLE INFORMATION AND NO TREND WAS IDENTIFIED. THE CHANGE IN PHYSICAL STATE OF THE MATERIAL WAS POTENTIALLY THE RESULT OF A RANDOM EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER STATES THIS LOT WAS FOUND WITH 3 SYRINGES WITH SMALL PLASTIC PIECES INSIDE THE BARREL ON THE PLUNGER THAT COULD POTENTIALLY BE INJECTED IF USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428860 3CC LL SYRINGE P-LK O/P SYRINGE FMI COVIDIEN 8881513934 524705X

    Patients

    Seq Age Sex Outcome Treatment
    1