BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE

    MDR report key: 13197796 · Received January 7, 2022

    Report

    Report Number
    9616656-2021-01626
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 14, 2021
    Report Date
    February 7, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. 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.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/2/2022. H.6. INVESTIGATION: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 1062594, CAT. NO. 320141. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. AS THE SAMPLE RETURNED WAS OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT HAD ANOTHER CLOGGED NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT HAD ANOTHER CLOGGED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993359 BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1062594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown