BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE, 3/10CC, 31G X 8MM

    MDR report key: 5998411 · Received October 4, 2016

    Report

    Report Number
    1920898-2016-00032
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CONSUMER DECLINED TO RETURN A SAMPLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY AND STERILITY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6011643. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, CAPA (B)(4) WAS INITIATED ON 8/16/2016 TO INVESTIGATE EXCESSIVE SILICONE AND IT IS CURRENTLY IN THE INVESTIGATION PHASE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTHER OF A DIABETIC PATIENT EXPRESSED AIR FROM APPROXIMATELY 10 BD ULTRA-FINE INSULIN SYRINGE, 3/10CC, 31G X 8MM AND LIQUID CAME OUT OF THE NEEDLES. THE CONSUMER STATED THAT SHE CALLED THE POLICE TO HER HOME AND WAS ADVISED TO GO TO THE HOSPITAL. SHE TOOK HER SON TO THE HOSPITAL FOR BLOOD WORK AND OTHER TESTS TO DETERMINE WHAT THE LIQUID MAY HAVE BEEN. NO OTHER INFORMATION WAS GIVEN AND THE INITIAL REPORTED DECLINED TO PROVIDE HER NAME, CONTACT INFORMATION, OR TO RETURN SAMPLE FOR EVALUATION. IT IS UNKNOWN IF THE SYRINGES IN QUESTION WERE ACTUALLY USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650273 BD ULTRA-FINE¿ INSULIN SYRINGE, 3/10CC, 31G X 8MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6011643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention