BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PRO PEN NEEDLE

    MDR report key: 11408716 · Received March 4, 2021

    Report

    Report Number
    9616656-2021-00213
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 7, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWENTY TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9226291, EIGHTEEN OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 0091912 AND ELEVEN OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9226293. VISUAL EXAMINATION OF THE TWENTY TWO SAMPLES FROM LOT. NO. 9226291 WAS CARRIED OUT AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON FIVE SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON SEVENTEEN SAMPLES. VISUAL EXAMINATION OF THE EIGHTEEN SAMPLES FROM LOT. NO. 0091912 WAS CARRIED OUT AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON SEVEN SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ELEVEN SAMPLES. VISUAL EXAMINATION OF THE ELEVEN SAMPLES FROM LOT. NO. 9226293 WAS CARRIED OUT AND BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON SIX SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON FIVE SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TESTING COULD BE CARRIED OUT. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE 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 ULTRA-FINE¿ PRO PEN NEEDLE EACH FROM LOTS 9226293, 9226291, AND 0091912 FAILED TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "INSULIN FLOW NOT CORRECT".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9226293, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-14. MEDICAL DEVICE LOT #: 9226291, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-14. MEDICAL DEVICE LOT #: 0091912, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-03-31. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ PRO PEN NEEDLE EACH FROM LOTS 9226293, 9226291, AND 0091912 FAILED TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "INSULIN FLOW NOT CORRECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307022 BD ULTRA-FINE PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1