BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 14961830 · Received July 8, 2022

    Report

    Report Number
    1920898-2022-00440
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 24, 2022
    Report Date
    August 3, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 18-JUL-2022. H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1ML BD INSULIN SYRINGE FROM LOT# 1242527. THE CUSTOMER REPORTED THAT THE FLANGES WERE BROKEN OFF. THE SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT 1 FLANGE WAS BROKEN. NO OTHER DAMAGE TO THE SYRINGE WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242527. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FLANGE BROKEN). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS WOULD CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD BROKEN THUMB PRESSES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTIVE SYRINGE... THE TIP ON ONE SIDE IS TOTALLY BROKEN OFF."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD BROKEN THUMB PRESSES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTIVE SYRINGE... THE TIP ON ONE SIDE IS TOTALLY BROKEN OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2862540 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1242527

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown