BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 8632160 · Received May 22, 2019

    Report

    Report Number
    1920898-2019-00476
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 7, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (55) 3/10CC, 6MM, 31G SYRINGES IN OPEN POLY BAGS WITH THE SHELF CARTON FROM LOT # 8043556. CUSTOMER STATES THAT THERE IS CLEAR LIQUID IN THE BARREL CLOSER TO THE STOPPER AREA. THIRTY OUT OF 55 RETURNED SYRINGES WERE EXAMINED AND 26 OUT OF 30 SAMPLES EXHIBITED A RING OF CLEAR MATERIAL ON THE INNER SURFACE OF THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8043556. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A VISUAL EVALUATION OF 55 SYRINGES FOUND NO EVIDENCE OF FM ON THE INSIDE OR OUTSIDE OF THE SYRINGE. A LIGHT CONTINUOUS FILM OF SILICONE IS VISIBLE ON THE ID OF THE BARREL, BUT THERE IS NO EVIDENCE OF EXCESS SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "VERBATIM: CONSUMER REPORTED FINDING CLEAR LIQUID IN BARREL CLOSER TO STOPPER AREA. STATED SHE DOES NOT USE THE SYRINGES IF SHE SEES THE LIQUID."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 OCCURRED WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "VERBATIM: CONSUMER REPORTED FINDING CLEAR LIQUID IN BARREL CLOSER TO STOPPER AREA. STATED SHE DOES NOT USE THE SYRINGES IF SHE SEES THE LIQUID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427865 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8043556 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other