BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10525734 · Received September 11, 2020

    Report

    Report Number
    2243072-2020-01417
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 16, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: SITE LEGAL NAME (FDA): DUN LAOGHAIRE. B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: BD ULTRA FINE¿ PEN NEEDLES. D.2. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. D.3. MEDICAL DEVICE MANUFACTURER: DUN LAOGHAIRE. D.2. MEDICAL DEVICE CATALOG #: 320122. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. D.4. MEDICAL DEVICE LOT #: 9275379. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: DUN LAOGHAIRE. G.5. PMA/510(K)#: K162516. H.4. DEVICE MANUFACTURE DATE: 2019-10-02.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WAS UNABLE TO DELIVER INSULIN DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THAT INSULIN PEN JAMS DURING INJECTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO AN UNKNOWN LOT NUMBER FOR DIFFICULT/UNABLE TO OPERATE. A REVIEW OF ALL RISK MANAGEMENT DOCUMENTS FOR THE PRODUCT FAMILY OF THE DEVICE INVOLVED IN THIS COMPLAINT (PEN NEEDLE, DIFFICULT/UNABLE TO OPERATE) , WAS PERFORMED AND IT WAS DETERMINED THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT WAS CAPTURED AND ADDRESSED INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK DUE TO AN UNKNOWN LOT NUMBER FOR DIFFICULT/UNABLE TO OPERATE. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED 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. 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 THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. IT WAS REPORTED THAT INSULIN PEN JAMS DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990171 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9275379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other