BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 8355951 · Received February 20, 2019

    Report

    Report Number
    9610847-2019-00178
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 31, 2019
    Report Date
    February 8, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: (B)(6) SAMPLES WERE RECEIVED FOR EVALUATION. THEY CAME IN THREE PLASTIC TRAYS. THEY WERE VISUALLY INSPECTED UNDER THE MICROSCOPE, FINDING NO FOREIGN MATTER. WHAT WAS OBSERVED IS THE EFFECT CREATED WHEN THE RUBBER STOPPERS TOUCHES THE BOTTOM PART OF THE BARREL, THE STOPPER IS LUBRICATED WITH MEDICAL GRADE SILICONE. AT THE MOMENT IT TOUCHES THE BOTTOM BARREL WALL IT CREATES AN OILY LIKE APPEARANCE. THERE IS NO EXCESS OF SILICONE ON ANY OF THE SAMPLES. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL, HOWEVER, SOME SILICONE MAY NOT BE PERFECTLY DISTRIBUTED. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR THE LOT #S 7173775, 7153545, 7173769 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #S 7173775, 7153545, 7173769 DURING THE PRODUCTION RUNS. ROOT CAUSE DESCRIPTION: SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL, HOWEVER, SOME SILICONE MAY NOT BE PERFECTLY DISTRIBUTED. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. RATIONALE: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE SYRINGES 20ML LL TIP CONV PAK EXPERIENCED FOREIGN MATTER CONTAMINATION NOTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149347 SYRINGE 20ML LL TIP CONV PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7269869 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other