BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 10841539 · Received November 15, 2020

    Report

    Report Number
    3002682307-2020-00344
    Event Type
    Malfunction
    Date Received
    November 15, 2020
    Date of Event
    October 21, 2020
    Report Date
    January 11, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 12/7/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2003239 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 INCIDENT, THE AFFECTED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, PARTICLES WERE OBSERVED WITHIN THE SYRINGE BARRELS. WE HAVE CONCLUDED THAT THE PARTICLES ARE COMPOSED OF THE SLIP AGENT USED IN THE MANUFACTURE OF THIS SYRINGE PRODUCT. THIS SLIP AGENT IS USED TO FACILITATE THE MOVEMENT OF THE PLUNGER ALONG THE BARREL. DURING THE MANUFACTURING PROCESS, THE LUBRICANT FORMS A MICROSCOPIC LAYER IN THE INTERNAL/EXTERNAL WALLS OF THE BARREL. WHEN THE PLUNGER IS MOVED BACKWARDS DURING THE FILLING OF THE SYRINGE, MOST OF THIS MICROSCOPE LAYER OF LUBRICANT IS DRAGGED BEHIND THE PLUNGER AND A SMALL QUANTITY STILL REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. THIS IS A NORMAL PROCESS AND THE SYRINGE WOULD NOT WORK WITHOUT THE PRESENCE OF THIS LUBRICANT. BASED ON THE EVALUATION CONDUCTED, IT IS CONCLUDED THAT THE REPORTED WHITE PARTICLES ARE INHERENT TO THE PRODUCT DESIGN AND MATERIAL AND SHOULD NOT REPRESENT ANY RISK IF THE PRODUCT IS USED ACCORDING TO THE NORMAL CLINICAL PRACTICES. IN RESPONSE TO THIS REPORT, CAPA#154923 HAS BEEN INITIATED TO PREVENT ISSUES RELATED TO THIS PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYRINGES S2 20ML CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR USERS HAVE ENCOUNTERED A PROBLEM WHEN USING A 2-PIECE 20ML SYRINGE REF 300296, LOT 2003239. THEY NOTICED THE APPEARANCE OF PLASTIC FILAMENTS AT THE BACK OF THE PLUNGER AFTER USE. AFTER VERIFICATION, THEY CONFIRM THAT THEY HAVE NOT REMOVED THE PLUNGER FROM THE BODY OF THE SYRINGE. CUSTOMER FOLLOW UP: -THE PROBLEM OCCURRED SEVERAL TIMES, THE SYRINGE KEPT FOR EXPERTISE CONTAINED AMOXICILLIN/CLAVULANIC ACID.".

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGES S2 20ML CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR USERS HAVE ENCOUNTERED A PROBLEM WHEN USING A 2-PIECE 20ML SYRINGE REF 300296, LOT 2003239. THEY NOTICED THE APPEARANCE OF PLASTIC FILAMENTS AT THE BACK OF THE PLUNGER AFTER USE. AFTER VERIFICATION, THEY CONFIRM THAT THEY HAVE NOT REMOVED THE PLUNGER FROM THE BODY OF THE SYRINGE. CUSTOMER FOLLOW UP: THE PROBLEM OCCURRED SEVERAL TIMES, THE SYRINGE KEPT FOR EXPERTISE CONTAINED AMOXICILLIN/CLAVULANIC ACID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306492 SYRINGE S2 20ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003239

    Patients

    Seq Age Sex Outcome Treatment
    1