BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 13402337 · Received January 31, 2022

    Report

    Report Number
    9616656-2022-00066
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 12, 2022
    Report Date
    February 3, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE CATALOG #: 320119; D.4. MEDICAL DEVICE LOT #: 1173028; D.4. MEDICAL DEVICE EXPIRATION DATE: 6/30/2026; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4); G.4. PMA / 510(K)#: K023264; H.4. DEVICE MANUFACTURE DATE: 6/22/2021. H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WOULD NOT FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE MORE THAN USUAL DUDS IN THIS ORDER. OF COURSE, I GET A COUPLE OF DUDS IN EVERY ORDER BUT THIS ONE SEEMS TO BE MORE THAN USUAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WOULD NOT FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE MORE THAN USUAL DUDS IN THIS ORDER. OF COURSE, I GET A COUPLE OF DUDS IN EVERY ORDER BUT THIS ONE SEEMS TO BE MORE THAN USUAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WOULD NOT FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE MORE THAN USUAL DUDS IN THIS ORDER. OF COURSE, I GET A COUPLE OF DUDS IN EVERY ORDER BUT THIS ONE SEEMS TO BE MORE THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510813 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1173028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown