BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    MDR report key: 11606353 · Received April 1, 2021

    Report

    Report Number
    9616656-2021-00341
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 8, 2021
    Report Date
    May 7, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    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: 2021-03-30. H6: INVESTIGATION SUMMARY: TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES AND THREE PHOTOS WERE RETURNED FROM AN UNKNOWN LOT. NO, CAT. NO.320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BENT NON PATIENT OF CANNULA WAS OBSERVED ON ONE SAMPLE AND A BROKEN NON PATIENT END CANNULA OF CANNULA WAS OBSERVED ON THE SECOND SAMPLE. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX CANNULA WAS BROKEN AND WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A BROKEN NEEDLE NPE AND A BENT NEEDLE NPE FROM A FEMALE PATIENT RECEIVING INSULIN WHO SWITCHED FROM NANO TO PRO. COMPLAINING THAT DRUG DIDN'T COME OUT, THE PATIENT BROUGHT PEN NEEDLES TO THE PHARMACY. THE PHARMACIST CONFIRMED THAT ONE NEEDLE NPE WAS BROKEN AND ONE NEEDLE NPE WAS BENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX CANNULA WAS BROKEN AND WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A BROKEN NEEDLE NPE AND A BENT NEEDLE NPE FROM A FEMALE PATIENT RECEIVING INSULIN WHO SWITCHED FROM NANO TO PRO. COMPLAINING THAT DRUG DIDN'T COME OUT, THE PATIENT BROUGHT PEN NEEDLES TO THE PHARMACY. THE PHARMACIST CONFIRMED THAT ONE NEEDLE NPE WAS BROKEN AND ONE NEEDLE NPE WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503816 PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX PEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1