BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM

    MDR report key: 11881364 · Received May 25, 2021

    Report

    Report Number
    9616656-2021-00587
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 5/28/2021. H6: INVESTIGATION: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND TWO PHOTOS WERE RETURNED FROM AN UNKNOWN LOT. NO., CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TESTING COULD BE CARRIED OUT. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. AS THE SAMPLE RETURNED WAS OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PEN NDL 32G 4MM NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT THE DRUG DIDN'T COME OUT AFTER ATTACHING THE PEN NEEDLE TO THE PEN. THE CONSUMER BROUGHT THE AFFECTED PRODUCT TO THE PHARMACY.

    Additional Manufacturer Narrative · 1

    REPORTED MEDICAL DEVICE LOT # : UNKNOWN - UNKNOWN DEVICE EXPIRATION DATE. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN FOR REPORTED UNKNOWN MEDICAL DEVICE LOT #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD PEN NDL 32G 4MM NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT THE DRUG DIDN'T COME OUT AFTER ATTACHING THE PEN NEEDLE TO THE PEN. THE CONSUMER BROUGHT THE AFFECTED PRODUCT TO THE PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772595 PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1