BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 8785699 · Received July 12, 2019

    Report

    Report Number
    1920898-2019-00654
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282890
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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# 8211554. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    MATERIAL NO: 328289 BATCH NO: 8211554. IT WAS REPORTED THAT DURING USE OF THE BD¿ ULTRA-FINE INSULIN SYRINGE WHEN THE CONSUMER WAS OPENING UP THE POLY BAG IN THE MIDDLE SHE GOT STABBED BY THE NEEDLE AND BLED A LITTLE. SHE DIDN'T HAVE TO PUT A BANDAGE ON. WHEN SHE OPENED THE BAG SHE FOUND THE NEEDLE SHIELD DETACHED FROM THE SYRINGE WAS IN THE BAG. NEEDLE GOT BENT AFTER IT POKED HER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN SHE WAS OPENING UP THE POLY BAG IN THE MIDDLE SHE GOT STABBED BY THE NEEDLE AND BLED A LITTLE. SHE DIDN'T HAVE TO PUT A BANDAGE. WHEN SHE OPENED THE BAG SHE FOUND THE NEEDLE SHIELD DETACHED FROM THE SYRINGE WAS IN THE BAG. NEEDLE GOT BENT AFTER IT POKED HER.

    Additional Manufacturer Narrative · 1

    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

    MATERIAL NO: 328289, BATCH NO: 8211554. IT WAS REPORTED THAT DURING USE OF THE BD¿ ULTRA-FINE INSULIN SYRINGE WHEN THE CONSUMER WAS OPENING UP THE POLY BAG IN THE MIDDLE, SHE GOT STABBED BY THE NEEDLE AND BLED A LITTLE. SHE DIDN'T HAVE TO PUT A BANDAGE ON. WHEN SHE OPENED THE BAG SHE FOUND THE NEEDLE SHIELD DETACHED FROM THE SYRINGE WAS IN THE BAG. NEEDLE GOT BENT AFTER IT POKED HER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN SHE WAS OPENING UP THE POLY BAG IN THE MIDDLE, SHE GOT STABBED BY THE NEEDLE AND BLED A LITTLE. SHE DIDN'T HAVE TO PUT A BANDAGE. WHEN SHE OPENED THE BAG, SHE FOUND THE NEEDLE SHIELD DETACHED FROM THE SYRINGE WAS IN THE BAG. NEEDLE GOT BENT AFTER IT POKED HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581082 BD ULTRA-FINE INSULIN SYRINGE INSULIN SYRINGE & NEEDLE FMF BD MEDICAL - DIABETES CARE 8211554 00382903282890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other