BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT SYRINGE S2

    MDR report key: 18218768 · Received November 28, 2023

    Report

    Report Number
    3002682307-2023-00336
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 7, 2023
    Report Date
    March 19, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903091102
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. AN ADDITIONAL LOT NUMBER WAS REPORTED FOR MATERIAL # 309110: BATCH 2211293 MFG 17 NOV 2022 EXP 31 OCT 2027.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBERS 2211293 AND 2307177. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS RELATED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, SEVERAL SHELF CARTONS OF SYRINGES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. AFTER A REVIEW OF THE RETURNED SAMPLES, WE WERE ABLE TO DETECT LUBRICANT FLAKES. THIS IS NOT CONSIDERED A DEFECT. THE OBSERVED 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT SYRINGE S2 HAD FLAKES IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A WHITE CRUMB CRUMBLED FROM THE PLUNGER OF THE SYRINGE. WHEN THE PISTON WAS MOVED BACK AND FORTH, MORE CHIPS CAME OUT. A WHITE CRUMB CRUMBLED FROM THE PLUNGER OF THE SYRINGE. WHEN DID THE INCIDENT OCCUR? DURING USE ADDITIONAL INFO RECEIVED - 06/NOV/2023 THE SYRINGES HAVE NOT DIRECTLY CAUSED HARM TO THE PATIENTS. THE FIRST TIME IT WAS NOTICED, THE NURSE WAS INJECTING MEDICINE WITH A SYRINGE AND HAD NOTICED LUMPS AMONG THE MEDICINE. THE NURSE WENT TO MAKE A NEW MEDICINE AND TOOK A DIFFERENT SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFO RECEIVED - 06/NOV/2023 THE SYRINGES HAVE NOT DIRECTLY CAUSED HARM TO THE PATIENTS. THE FIRST TIME IT WAS NOTICED, THE NURSE WAS INJECTING MEDICINE WITH A SYRINGE AND HAD NOTICED LUMPS AMONG THE MEDICINE. THE NURSE WENT TO MAKE A NEW MEDICINE AND TOOK A DIFFERENT SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532426 BD DISCARDIT SYRINGE S2 SYRINGE, PISOTN FMF BECTON DICKINSON, S.A. 2307177 00382903091102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown