BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE

    MDR report key: 7399114 · Received April 5, 2018

    Report

    Report Number
    9616656-2018-00078
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    March 26, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: INVESTIGATION SUMMARY: CUSTOMER RETURNED ( 6 ) 8MM, 31G BD PEN NEEDLES; 4 WERE RECEIVED WITHOUT THE TEAR DROP LABEL AND THE REMAINING 2 WERE CLOSED/SEALED. CONSUMER REPORTED INNER SHIELD DIFFICULT TO REMOVE, TEAR DROP LABEL DIFFICULT TO REMOVE, TEAR DROP LABEL APPEARS MORE SHINY IN THE LAST TWO BOXES SHE HAS USED. CONSUMER REPORTED RASH AND BUMPS IN INJECTION SITE ONLY AND ITCHY. ALL RETURNED PEN NEEDLES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 4 OPEN RECEIVED HAD NO OUTER COVER, BUT HAD THE INNER SHIELD - REMOVED INNER SHIELD WITHOUT ANY DIFFICULTY FOR ALL 4 RETURNED NEEDLES. 2 RECEIVED SEALED, TESTED AND BOTH THE TEAR DROP LABEL AS WELL AS THE INNER SHIELD COULD BE REMOVED WITHOUT ANY DIFFICULTY. THE APPEARANCE OF THE TEAR DROP LABEL WAS PER SPECIFICATION (NOT DISCOLORED). A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. SEVERITY: S3; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DOES NOT DETACH (INNER SHIELD & TEAR DROP LABEL), DISCOLORED AND HARM ON LOT # 7200548. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE THE CONSUMER REPORTED INNER SHIELD DIFFICULT TO REMOVE, TEAR DROP LABEL DIFFICULT TO REMOVE, TEAR DROP LABEL APPEARS MORE SHINY IN THE LAST TWO BOXES SHE HAS USED. CONSUMER STATED SHE WAS SEEN BY HER DOCTOR AND PRESCRIBED A TOPICAL WASH. CONSUMER REPORTED RASH AND BUMPS IN INJECTION SITE ONLY AND ITCHY. STATED THE RASH IS NOT FROM INSULIN THAT'S BEING USED. STATED HER DOCTOR SAID IT IS A BACTERIAL INFECTION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241921 BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7200548 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention