BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN

    MDR report key: 10687997 · Received October 15, 2020

    Report

    Report Number
    3002682307-2020-00313
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 23, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1811404 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, PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH EXAMINATION OF THE PICTURES, WHITE FOREIGN MATTER WAS OBSERVED ON THE BARREL COMPONENT. THE FOREIGN MATTER WAS IDENTIFIED AS LUBRICANT FLAKES, COMPOSED BY THE LUBRICANT USED WITHIN THE SYRINGE BARREL. THE LUBRICANT FLAKES ARE VISIBLE BY THE NAKED EYE AND CONSIST OF AN ACCUMULATION OF THE SLIP AGENT, WHICH IS USED DURING THE MANUFACTURE OF THE SYRINGE. THE SLIP AGENT IS USED TO FACILITATE 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. THIS LUBRICANT IS INCLUDED IN THE PLASTIC FORMULATION AND IT IS INHERENT TO THE DESIGN AND FUNCTION OF 2 PIECE SYRINGES. TOXICOLOGIC MATERIAL RISK ASSESSMENT FOR AMIDE SLIP AGENTS USED IN BD SYRINGES INDICATE AN EXTREMELY LOW TO NEGLIGIBLE RISK OF MATERIALS-MEDICATED ADVERSE EFFECT IN THIS CLINICAL APPLICATION. TAKING INTO ACCOUNT 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. ALTHOUGH THE PERCENTAGE OF SLIP AGENT IN THE PRODUCT IS ESTABLISHED AND CONTROLLED ACCORDING TO THE BD PRODUCT SPECIFICATIONS, IN ORDER TO REDUCE THE AMOUNT OF SLIP AGENT USED, THE AMOUNT OF SLIP AGENT ADDED TO THE SYRINGE BARREL HAS BEEN ADJUSTED TO THE LOW END OF THE SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4800 SYRINGES SOLOMED 2PC 2ML 25X5/8 FIXED CN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE HOSPITAL NURSE WAS DRAWING THE VACCINE IN THE VACCINATION ROOM, HE FOUND MANY WHITE FLOCCULENT OBJECTS ON THE INNER WALL OF THE SYRINGE. 2020-09-27 RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE, THE EVENT DESCRIPTION IS UPDATED AS FOLLOWS: THE CUSTOMER REFERRED TO "PRODUCT IN USE" TO PREPARE FOR INJECTION, AND A FOREIGN MATTER WAS FOUND WHEN THE PACKAGE WAS OPENED, WHICH WAS NOT USED ON THE PATIENT."

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4800 SYRINGES SOLOMED 2PC 2ML 25X5/8 FIXED CN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE HOSPITAL NURSE WAS DRAWING THE VACCINE IN THE VACCINATION ROOM, HE FOUND MANY WHITE FLOCCULENT OBJECTS ON THE INNER WALL OF THE SYRINGE. (B)(6) 2020 RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE, THE EVENT DESCRIPTION IS UPDATED AS FOLLOWS: THE CUSTOMER REFERRED TO "PRODUCT IN USE" TO PREPARE FOR INJECTION, AND A FOREIGN MATTERWAS FOUND WHEN THE PACKAGE WAS OPENED, WHICH WAS NOT USED ON THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152624 SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1811404

    Patients

    Seq Age Sex Outcome Treatment
    1 Other