BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7562794 · Received June 1, 2018

    Report

    Report Number
    2243072-2018-00351
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 14, 2018
    Report Date
    June 11, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CATALOG # AND LOT # ADDED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BD ULTRA FINE¿ INSULIN PEN NEEDLE DETACHED FROM THE HUB DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS. MEDICAL DEVICE BRAND NAME: BD ULTRA FINE¿ INSULIN PEN NEEDLE MEDICAL DEVICE MANUFACTURER: DUN LAOGHAIRE, IRELAND MEDICAL DEVICE CATALOG #: 320145 UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: DUN LAOGHAIRE, IRELAND PMA / 510(K)#: K131358 LOT # PROVIDED: 5120112 MEDICAL DEVICE EXPIRATION DATE: 03/31/2020 DEVICE MANUFACTURE DATE: 05/25/2015.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) OPEN 5MM, 31G PEN NEEDLE WITHOUT THE OUTER COVER FROM LOT # 5120112. CUSTOMER STATES THAT THE NEEDLE SLIPPED OUT OF HUB AND STAYED IN CARTRIDGE. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A DETACHED CANNULA. 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: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE SEPARATES ON LOT # 5120112. BASED ON THE SAMPLES / PHOTO(S) RECEIVED BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THE PROBABLE ROOT CAUSES FOR THIS ISSUE ARE: INCOMPLETE ADHESIVE CURE - UV BULB INTENSITY IS INSUFFICIENT, BELT SPEED THROUGH THE UV OVEN IS TOO FAST. INSUFFICIENT ADHESIVE - IMPROPER CANNULATION AND ADHESIVE APPLICATION, ADHESIVE RUNS OUT OF THE HUB ADHESIVE WELL. RE-USE - MULTIPLE INJECTIONS WITH THE SAME DEVICE CAN CAUSE TOO MUCH PRESSURE ON THE NEEDLE. 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 AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ULTRA FINE¿ INSULIN PEN NEEDLE DETACHED FROM THE HUB DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    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 AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. NO MATERIAL # PROVIDED. NO LOT # PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 AN UNSPECIFIED BD¿ PEN NEEDLE DETACHED FROM THE HUB DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404427 BD ULTRA FINE¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 5120112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other