BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 7283330 · Received February 20, 2018

    Report

    Report Number
    3002682307-2018-00029
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    November 8, 2017
    Report Date
    March 2, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SAMPLE EVALUATION WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. NO DEFECT WAS FOUND IN THE PROVIDED SAMPLE. BHR REVIEW; WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (SEPTEMBER 3 - 4TH, 2016). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #6242446 (AUGUST 29TH - SEPTEMBER 5TH, 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6239275, AND #6230486 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6239384, AND #6230008 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS BASED ON THE CUSTOMER DESCRIPTION, WE CONSIDER THAT THE PARTICLES INSIDE THE SYRINGE COULD BE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. THE LUBRICANT IS INCLUDED IN THE PLASTIC FORMULATION AND IT IS INHERENT TO THE DESIGN AND FUNCTION OF 2 PIECE SYRINGES. 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. THE PRESENCE PARTICLES OF LUBRICANT IN THE FLUID PATH OF DISCARDIT II SYRINGES HAS BEEN EVALUATED BY BD. THE POLYPROPYLENE USED TO PRODUCE THE SYRINGE BARRELS (WITH THE SLIP AGENT INCLUDED IN THE FORMULATION) HAS PASSED ALL THE BIOCOMPATIBILITY TESTS REQUIRED PRIOR TO MARKETING THE PRODUCT AND MEET THE ESTABLISHED CRITERIA FOR PRECLINICAL TOXICOLOGICAL SAFETY EVALUATIONS. SHOULD ANY LUBRICANT PARTICLES ENTER THE FLUID PATHWAY THEN THE RISK TO THE PATIENT BASED ON TOXICOLOGICAL OR PHYSICAL OCCLUSION OF BLOOD VESSELS IS DEEMED AS NEGLIGIBLE AND CLINICALLY INSIGNIFICANT. CONFIRMATION THE PROVIDED SAMPLE DID NOT PRESENT THE REPORTED ISSUE. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: ALTHOUGH THE DEFECT WAS NOT VERIFIED FOR THIS INSTANCE, BD RECENTLY INVESTIGATED A SIMILAR COMPLAINT, APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND ARE LOOKING FURTHER INTO THIS ISSUE. WE HAVE INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT FOREIGN MATTER DESCRIBED AS ¿PLASTIC DEPOSITS¿ WERE FOUND IN A DISCARDIT¿ II SYRINGE W/O NEEDLE WHEN DRAWING UP MEDICATION. THE SYRINGE WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126094 DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1609134

    Patients

    Seq Age Sex Outcome Treatment
    1 Other