BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 11457191 · Received March 10, 2021

    Report

    Report Number
    3002682307-2021-00085
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 20, 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: 2021-03-09. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 2005183, 2005225, 2004269, 1905181, AND 2004212 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, PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, WHITE PARTICLES WERE OBSERVED WITHIN THE SYRINGES. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE S2 20ML HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "INCIDENT WAS REPORTED IN THE OR. CUSTOMER SEE FLAKES IN SYRINGE".

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: (B)(4) A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE S2 20ML HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "INCIDENT WAS REPORTED IN THE OR. CUSTOMER SEE FLAKES IN SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351784 SYRINGE S2 20ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1