BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 13168580 · Received January 5, 2022

    Report

    Report Number
    1920898-2021-01365
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 7, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-06. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 0.5ML BD INSULIN SYRINGE FROM LOT# 1053390. THE CUSTOMER REPORTED ABOUT NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE BARREL TIP OF THE SYRINGE WAS BROKEN. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1053390. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BARREL TIP BROKEN). ROOT-CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED WHILE REMOVING THE SHIELD FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE NEEDLE FELL OUT, ALONG WITH THE CAP." THE CUSTOMER REPORTED ABOUT NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED WHILE REMOVING THE SHIELD FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE NEEDLE FELL OUT, ALONG WITH THE CAP." THE CUSTOMER REPORTED ABOUT NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443833 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1053390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown