BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO FINE PLUS INSULIN PEN NEEDLE

    MDR report key: 8709135 · Received June 18, 2019

    Report

    Report Number
    9616656-2019-00546
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 4, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS, THEREFORE, THE INVESTIGATION WAS LIMITED. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NON-PATIENT END OF THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE "GRAZED" THE PHARMACIST'S FINGER AFTER IT HAD BEEN RECEIVED FROM THE PATIENT, WHO WAS REPORTEDLY ON FORTEO. HOWEVER, NO MEDICAL INTERVENTION OR FURTHER DETAILS HAVE BEEN RECEIVED FROM THE CUSTOMER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IT WAS REPORTED THAT THE USED NEEDLE NPE GRAZED THE PHARMACIST'S FINGER WHEN S/HE RECEIVED IT FROM THE PATIENT. THE PATIENT USES FORTEO. THE PHARMACIST QUESTIONED ABOUT POSSIBILITY OF INFECTIOUS DISEASES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501811 BD MICRO FINE PLUS INSULIN PEN NEEDLE PISTON SYRINGE FMF BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other