BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 8795696 · Received July 16, 2019

    Report

    Report Number
    2243072-2019-01438
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    July 2, 2019
    Report Date
    August 15, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT TWO BD ULTRA-FINE¿ PEN NEEDLES EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION AND DIFFICULT OPERATION OR NOT WORKING/FUNCTIONING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLOGGED NEEDLES. D.1. MEDICAL DEVICE BRAND NAME: BD ULTRA-FINE¿ PEN NEEDLE; D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. (DUN LAOGHAIRE); D.4. MEDICAL DEVICE CATALOG #: 320489; D.4. MEDICAL DEVICE LOT #: 8227644; D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4); G.1. MANUFACTURING LOCATION: BECTON DICKINSON AND CO. (DUN LAOGHAIRE); G.5. PMA / 510(K)#: N/A; H.4. DEVICE MANUFACTURE DATE: 2018-08-15. H.6. INVESTIGATION: 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. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD ULTRA-FINE¿ PEN NEEDLES EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION AND DIFFICULT OPERATION OR NOT WORKING/FUNCTIONING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLOGGED NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO UNSPECIFIED BD PEN NEEDLES EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION AND DIFFICULT OPERATION OR NOT WORKING/FUNCTIONING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLOGGED NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590369 BD ULTRA-FINE¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8227644

    Patients

    Seq Age Sex Outcome Treatment
    1 Other