BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE

    MDR report key: 17035630 · Received May 31, 2023

    Report

    Report Number
    1920898-2023-00324
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 8, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE VIDEO PROVIDED. THE CUSTOMER RETURNED A VIDEO OF THE 31GX6MM BD SYRINGE. THE CUSTOMER REPORTED THAT WHEN THE INSULIN SYRINGE CAP WAS OPENED THERE WAS A YELLOWISH PART NEAR NEEDLE END. THE VIDEO WAS EXAMINED, AND THERE APPEARS TO BE A BROWNISH COLOR STAIN AROUND THE RIM/TIP OF THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2052405. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE PHOTOS RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOREIGN MATTER ON BARREL TIP). THERE WERE NO QUALITY NOTIFICATIONS OR DISPATCHES THAT PERTAINED TO THE COMPLAINT; THEREFORE, NO ROOT CAUSE CAN BE DETERMINED.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 300 BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGES' CAPS WERE DISCOLORED TO YELLOW NEAR THE NEEDLE POINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THEY OPEN INSULINE SYRINGE CAP YELLOWISH PART NEAR NEEDLE END."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 300 BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGES' CAPS WERE DISCOLORED TO YELLOW NEAR THE NEEDLE POINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THEY OPEN INSULINE SYRINGE CAP YELLOWISH PART NEAR NEEDLE END."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682141 BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown