BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9234223 · Received October 24, 2019

    Report

    Report Number
    1920898-2019-01191
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 7, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908431033
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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# 9112598. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    MATERIAL NO. 328431 BATCH NO. 9112598. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE CONSUMER WAS UNABLE TO REMOVE THE ORANGE NEEDLE SHIELD AND IT WAS SO HARD HER FINGER GOT SORE. IT WAS ADDITIONALLY REPORTED THAT THE NEEDLE HUB SEPARATED. THIS OCCURRED ON 18 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED UNABLE TO REMOVE THE ORANGE NEEDLE SHIELD, NEEDLE HUB SEPARATED. IT WAS VERY HARD HER FINGER GOT SORE. DID NOT SEEK MEDICAL ATTENTION. SHE USES THE NEW SYRINGES EACH TIME OF HER INJECTION.

    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. 328431 BATCH NO. 9112598. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE CONSUMER WAS UNABLE TO REMOVE THE ORANGE NEEDLE SHIELD AND IT WAS SO HARD HER FINGER GOT SORE. IT WAS ADDITIONALLY REPORTED THAT THE NEEDLE HUB SEPARATED. THIS OCCURRED ON 18 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED UNABLE TO REMOVE THE ORANGE NEEDLE SHIELD, NEEDLE HUB SEPARATED. IT WAS VERY HARD HER FINGER GOT SORE. DID NOT SEEK MEDICAL ATTENTION. SHE USES THE NEW SYRINGES EACH TIME OF HER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030789 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9112598 00382908431033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other