BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 6MM

    MDR report key: 10336246 · Received July 28, 2020

    Report

    Report Number
    1920898-2020-00944
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 5, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 7/31/2020 H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) LOOSE 31GX6MM, 0.3ML BD INSULIN SYRINGE. CONSUMER REPORTED WHEN REMOVING THE PLUNGER CAP FROM 2 INSULIN SYRINGES, THE PLUNGER ROD IS LOOSE AND JUST FALLS OUT OF THE BARREL. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE PLUNGER ROD WAS PROPERLY ATTACHED TO THE RUBBER STOPPER WITHIN THE SYRINGE BARREL. TESTING THE PLUNGER ROD MOVEMENT OF THE PLUNGER ROD ASSEMBLY WITHIN THE SYRINGE BARREL DID NOT RESULT IN PLUNGER ROD SEPARATION. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200845676, 200845567, 200845495] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE PLUNGER IS LOOSE AND FALLS OUT WITH 2 BD SYRINGE 0.3ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED WHEN REMOVING THE PLUNGER CAP FROM 2 INSULIN SYRINGES, THE PLUNGER ROD IS LOOSE AND JUST FALLS OUT OF THE BARREL.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE PLUNGER IS LOOSE AND FALLS OUT WITH 2 BD SYRINGE 0.3ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED WHEN REMOVING THE PLUNGER CAP FROM 2 INSULIN SYRINGES, THE PLUNGER ROD IS LOOSE AND JUST FALLS OUT OF THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799578 BD SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other