BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 10460725 · Received August 27, 2020

    Report

    Report Number
    3002682307-2020-00261
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 6, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/2/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2002112 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, WHITE PARTICLES WERE OBSERVED WITHIN THE SYRINGE. THE WHITE PARTICLES WERE IDENTIFIED AS LUBRICANT FROM THE SYRINGE BARREL. THIS LUBRICANT IS INCLUDED IN THE PLASTIC FORMULATION AND IS INHERENT TO THE DESIGN AND FUNCTION OF THE TWO PIECE SYRINGE. THE NORMAL FUNCTIONALITY OF THE SYRINGE WOULD NOT WORK WITHOUT THE PRESENCE OF THIS LUBRICANT. DURING THE MANUFACTURING PROCESS, THE LUBRICANT FORMS A MICROSCOPIC LAYER IN THE INTERNAL AND EXTERNAL WALLS OF THE BARREL. WHEN THE PLUNGER IS MOVED BACKWARDS DURING THE FILLING OF THE SYRINGE, MOST OF THIS MICROSCOPIC LAYER OF LUBRICANT IS DRAGGED BEHIND THE PLUNGER AND A SMALL QUANTITY STILL REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION PROCESS. THE MOST RESTRICTIVE REGULATIONS FROM DIFFERENT COUNTRIES SPECIFY THE MAXIMUM AMOUNT OF LUBRICANT AND THE TWO-PIECE BD SYRINGE IS BELOW THAT LIMIT. TOXICOLOGICAL TESTING OF THE SLIP AGENT HAS INDICATED AN EXTREMELY LOW TO NEGLIGIBLE RISK FOR THE APPLICATION OF THIS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML HAD FOREIGN MATTER INSIDE OF THE SYRINGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTING OF LOOSE PIECES OF PLASTIC IN THE DISCARDIT 20ML SYRINGES. THE PLASTIC IS ACTUALLY BEING INJECTED INTO THE HORSES WHEN BEING USED. -DATE WHEN THE LOOSE PLASTIC PIECES WERE NOTICED? SOMETIME LAST WEEK. -WHERE DID THE PROBLEM OCCUR? REMOVED THE PLUNGER TO ADD SEMEN AND NOTICED THE LOOSE PIECES. -IN HOW MANY SYRINGES? AT LEAST 10 SYRINGES THEN USED SYRINGES OUT OF MY CAR OF ANOTHER BATCH. -HOW MANY HORSES WERE AFFECTED? HARD TO SAY SINCE WE DON¿T ALWAYS REMOVE THE PLUNGER SOME VETS ASPIRATE THE SEMEN INTO THE SYRINGE AND SINCE SEMEN/SEMEN EXTENDER IS WHITE YOU WOULD NOT NOTICE IT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 20ML HAD FOREIGN MATTER INSIDE OF THE SYRINGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTING OF LOOSE PIECES OF PLASTIC IN THE DISCARDIT 20ML SYRINGES. THE PLASTIC IS ACTUALLY BEING INJECTED INTO THE HORSES WHEN BEING USED. -DATE WHEN THE LOOSE PLASTIC PIECES WERE NOTICED? SOMETIME LAST WEEK. -WHERE DID THE PROBLEM OCCUR? REMOVED THE PLUNGER TO ADD SEMEN AND NOTICED THE LOOSE PIECES. -IN HOW MANY SYRINGES? AT LEAST 10 SYRINGES THEN USED SYRINGES OUT OF MY CAR OF ANOTHER BATCH. -HOW MANY HORSES WERE AFFECTED? HARD TO SAY SINCE WE DON¿T ALWAYS REMOVE THE PLUNGER SOME VETS ASPIRATE THE SEMEN INTO THE SYRINGE AND SINCE SEMEN/SEMEN EXTENDER IS WHITE YOU WOULD NOT NOTICE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928136 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. 2002112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other