BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN SYRINGE

    MDR report key: 3009221 · Received March 14, 2013

    Report

    Report Number
    1920898-2013-00004
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BD
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE: CANNULA BROKEN OFF. EVAL SUMMARY: CUSTOMER RETURNED (1) 1CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 2192084. CUSTOMER STATES THAT SHE HAD A NEEDLE BREAK OFF AFTER HER INJECTION. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN CANNULA. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACK ADHESIVE, AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE ADHESIVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #2192084. THERE WERE 0 DEFECTS OR NOTIFICATIONS RELATING TO COMPLAINT DEFECT NOTED DURING THE PRODUCTION OF THIS FINISHED BATCH. COMPLAINT HISTORY CHECK WAS PERFORMED AND AS OF (3/7/2013), THIS IS THE 1ST COMPLAINT AGAINST LOT NUMBER 2192084 FOR NEEDLE BREAK OFF ISSUES. INFO WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT AFTER GIVEN HERSELF AN INJECTION OF (85) UNITS OF HUMALIN N, WENT TO REMOVE THE NEEDLE AND IT WAS GONE. CONSUMER FELT NEEDLE IN HER SKIN AND WAS SQUEEZING THE AREA TRYING TO GET THE NEEDLE OUT. CONSUMER CALLED HER DOCTOR AND HE TOLD HER TO GOT THE ER OR URGENT CARE TO GET IT LOOKED AT. X-RAY AND CT-SCAN WERE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108420 BD INSULIN SYRINGE INSULIN SYRINGE FMF BD 2192084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention