BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE

    MDR report key: 7375200 · Received March 27, 2018

    Report

    Report Number
    2243072-2018-00150
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 3, 2018
    Report Date
    April 4, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FOR THE MEDICAL DEVICE LOT NUMBER(S), CATEGORY NUMBER (S), MANUFACTURING/EXPIRATION DATE(S), MANUFACTURING LOCATION. THE FOLLOWING FIELD(S) HAVE BEEN UPDATED: (B)(4). MEDICAL DEVICE BRAND NAME: BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE. MEDICAL DEVICE MANUFACTURER: (B)(4), MEDICAL DEVICE CAT #: 320109, MEDICAL DEVICE LOT #: 7164623, UDI: (B)(4), MEDICAL DEVICE EXPIRATION DATE: N/A, MANUFACTURING LOCATION: (B)(4), 510K: K162516, DEVICE MANUFACTURE DATE: 2017-06-13. INVESTIGATION RESULTS: SEVERITY: S12; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE THROUGH SHIELD AND NEEDLE STICK ON LOT # 7164623. CUSTOMER RETURNED ( 1 ) 8MM, 31G BD PEN NEEDLE WITHOUT THE TEAR DROP LABEL. CUSTOMER REPORTED THE NEEDLE WAS THROUGH THE SHIELD. THE RETURNED PEN NEEDLE WAS EXAMINED AND IT EXHIBITED THE NEEDLE THROUGH THE INNER SHIELD. 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. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION REQUIRED AT THIS TIME. THE POTENTIAL ROOT CAUSE OF THIS ISSUE LIES AT THE SHIELDING STATION IN BD ASSEMBLY PROCESS. IF THE NEEDLE IS PRESENTED TO THE SHIELDER OBLIQUELY, THE DOWNWARD MOVEMENT OF THE EMPTY SHIELD RESULTS IN THE NEEDLE PENETRATING THE SHIELD. CAPA (B)(4) RAISED FOR NEEDLE THROUGH SHIELD ISSUE.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 THAT A NEEDLE WENT THROUGH THE SHIELD ON AN UNKNOWN BD PEN NEEDLE BREACHING STERILITY AND RESULTING IN A CONSUMER¿S NEEDLE STICK TO THE THUMB. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215966 BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 7164623

    Patients

    Seq Age Sex Outcome Treatment
    1 Other