BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31G 8MM WHOLEUNIT

    MDR report key: 9699789 · Received February 12, 2020

    Report

    Report Number
    1920898-2020-00120
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 27, 2020
    Report Date
    January 28, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SYRINGE. CUSTOMER STATES THAT THEY ARE SEEING A PIECE OF FIBER FLOATING INSIDE THE BARREL AND THE PLUNGERS ARE DIFFICULT TO MOVE ON ALL SYRINGES. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED A PIECE OF MATERIAL IN THE BARREL OF THE SYRINGE. IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE ATTACHED PHOTOS. THE SYRINGE SHOWN IN THE PHOTOS ALSO EXHIBITED A CLOUDY LIQUID THAT HAD BEEN DRAWN INTO THE BARREL INDICATING THAT THE SYRINGE WAS ABLE TO DRAW PROPERLY WITHOUT ANY DEFECTS. SEE ATTACHED PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAIN. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FM).UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DIFFICULT TO MOVE PLUNGER). ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE 0.3ML 31G 8MM WAS FOUND TO HAVE FOREIGN MATTER IN THE FLUID PATHWAY AND DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED THAT AFTER DRAWING INSULIN, PET OWNER IS SEEING A PIECE OF FIBER FLOATING INSIDE THE BARREL. IT WAS ALSO REPORTED THAT THE PLUNGERS ARE DIFFICULT TO MOVE ON ALL SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166926 BD SYRINGE 0.3ML 31G 8MM WHOLEUNIT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9161986 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other