BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 13319505 · Received January 21, 2022

    Report

    Report Number
    1920898-2022-00026
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 30, 2021
    Report Date
    February 1, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (2) LOOSE 0.5ML BD INSULIN SYRINGES. THE CUSTOMER REPORTED THAT THE NEEDLE HUB SEPARATED, NEEDLE SHIELDS ARE HARDER TO REMOVE, AND THE NEEDLE ONLY SEPARATED FROM THE SYRINGE WHEN THE NEEDLE SHIELD WAS REMOVED. THE RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS DETACHED FROM EACH BARREL. DAMAGE WAS OBSERVED TO THE BARREL TIP AND CANNULA HUB OF ONE SAMPLE; NO DAMAGE TO THE BARREL TIP OR CANNULA HUB WAS OBSERVED ON THE OTHER SAMPLE. IT WAS OBSERVED THAT THE CANNULA FOR EACH DETACHED HUB ASSEMBLY WAS STILL ATTACHED AFTER REMOVING THE RESPECTIVE CANNULA SHIELDS, THEREFORE, THE ALLEGED NEEDLE SEPARATES ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1130863. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NEEDLE ASSEMBLY SEPARATE). CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE FOR HUB SEPARATES (NEEDLE ASSEMBLY SEPARATE). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN HE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED. STATED, WHEN HE REMOVED NEEDLE SHIELD, THE NEEDLE ONLY SEPARATED FROM SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN HE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED. STATED, WHEN HE REMOVED NEEDLE SHIELD, THE NEEDLE ONLY SEPARATED FROM SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902317 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 1130863 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown