BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 15649351 · Received October 21, 2022

    Report

    Report Number
    3002682307-2022-00281
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 18, 2022
    Report Date
    November 15, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 18-OCT-2022 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED MATERIAL NUMBER 300296 AND LOT NUMBER 2203234. 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, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, WHITE PARTICLES WERE OBSERVED WITHIN THE FLUID PATHWAY. 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 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 OPERATION. THIS IS A NORMAL PROCESS AND THE SYRINGE WOULD NOT WORK WITHOUT THE PRESENCE OF THIS LUBRICANT. THE MOST RESTRICTIVE FOOD ADDITIVES REGULATIONS FROM DIFFERENT COUNTRIES ALLOW A MAXIMUM LEVEL OF 0.2 % OF LUBRICANT. THE SPECIFICATION FOR THE QUANTITY OF LUBRICANT USED IN THE BARREL OF BD TWO-PIECE SYRINGES IS BELOW THIS LIMIT. A TOXICOLOGIC MATERIAL RISK ASSESSMENT FOR THE SLIP AGENTS USED IN BD DISCARDIT II 2-PIECE SYRINGES INDICATE AN EXTREMELY LOW TO NEGLIGIBLE RISK OF ADVERSE EFFECT IN THIS CLINICAL APPLICATION. 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PULLING BACK THE PLUNGER IN A 20 MM LUER DISPOSABLE SYRINGE, FINE PLASTIC IMPURITIES WERE NOTICED INSIDE THE SYRINGE. THEY MOVED ALONG WITH THE PLUNGER POSING A THREAT TO PATIENTS IF ENTERED INTO VENFLONS OR INFUSION SOLUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PULLING BACK THE PLUNGER IN A 20 MM LUER DISPOSABLE SYRINGE, FINE PLASTIC IMPURITIES WERE NOTICED INSIDE THE SYRINGE. THEY MOVED ALONG WITH THE PLUNGER POSING A THREAT TO PATIENTS IF ENTERED INTO VENFLONS OR INFUSION SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2461600 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown