BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE

    MDR report key: 14246944 · Received April 28, 2022

    Report

    Report Number
    1920898-2022-00303
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 6, 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

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. PHOTOS OF A 0.5ML BD INSULIN SYRINGE WERE PROVIDED. THE CUSTOMER REPORTED THAT THE NEEDLE WITH THE SHIELD WAS SEPARATED FROM THE BARREL. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS DETACHED FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE SHIELD WAS REMOVED, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE EXPERIECNED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE SHIELD WAS REMOVED, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142373 BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown