BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2 ML SYRINGE

    MDR report key: 10892791 · Received November 24, 2020

    Report

    Report Number
    3002682307-2020-00358
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    November 11, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-12-28. H6: INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2002206 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, THE AFFECTED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, PARTICLES WERE OBSERVED WITHIN THE SYRINGE BARREL. 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. 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. IN RESPONSE TO THIS REPORT, A CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA) 1549223 HAS BEEN INITIATED TO PREVENT ISSUES RELATED TO THIS PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD DISCARDIT¿ II 2 ML SYRINGES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN PARTICLES/FLOCCULATION IN THE SYRINGE, STRONG STREAKS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 100 BD DISCARDIT¿ II 2 ML SYRINGES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN PARTICLES/FLOCCULATION IN THE SYRINGE, STRONG STREAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355975 BD DISCARDIT II 2 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2002206

    Patients

    Seq Age Sex Outcome Treatment
    1