BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 17221240 · Received June 28, 2023

    Report

    Report Number
    1920898-2023-00405
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466011
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1221996. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. H.3. 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 DURING USE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE SCALE MARKINGS WERE DISCOVERED TO BE MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALSO THE UNIT MARKINGS ARE INCONSISTENT, GENERALLY FURTHER DOWN THE BARREL THAN USUAL OR ALIGNED CROOKED. I HAVE HAD SEVERAL STRANGE LOWS SINCE 2020 & KNOW IT IS DUE TO THESE SYRINGES, SO I PLAN TO DISCONTINUE BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE SCALE MARKINGS WERE DISCOVERED TO BE MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALSO THE UNIT MARKINGS ARE INCONSISTENT, GENERALLY FURTHER DOWN THE BARREL THAN USUAL OR ALIGNED CROOKED. I HAVE HAD SEVERAL STRANGE LOWS SINCE 2020 & KNOW IT IS DUE TO THESE SYRINGES, SO I PLAN TO DISCONTINUE BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168803 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1221996 00382908466011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown