BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 15479199 · Received September 24, 2022

    Report

    Report Number
    9616656-2022-01036
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 8, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903251056
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 15-SEP-2022. H6: INVESTIGATION SUMMARY: ONE 31G X 8MM PEN NEEDLE CARTON WAS RETURNED FROM LOT. NO. 8185560, CAT. NO. 325105. VISUAL EXAMINATION OF THE RETURNED CARTON WAS CARRIED OUT AND TAPE WHICH IS NOT APPLIED DURING THE MANUFACTURING PROCESS WAS OBSERVED COVERING THE CLOSURE LABEL ON THE CARTON. OBSERVED INSIDE THE CARTON WAS FIVE SEALED 31G X 8MM PEN NEEDLE SAMPLES FROM LOT. NO. 0022841, CAT. NO. 320524, NINETEEN SEALED 31G X 8MM PEN NEEDLE SAMPLES FROM LOT. NO. 8185560, CAT. NO. 325105 ALONG WITH ONE HUNDRED AND SEVEN SEALED 31G X 6 PEN NEEDLE SAMPLES FROM LOT. NO. 0063230, CAT. NO. 320523. 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. LOT. NO. 8185560 WAS MANUFACTURED ON LINES 5, 7 AND 10, SEPTEMBER 7TH TO 9TH 2018 AND PACKAGED ON 656, SEPTEMBER 8TH 2018. LOT. NO. 0022841 WAS MANUFACTURED ON LINES 5, 7 AND 10, MARCH 3RD TO 4TH 2020 AND PACKAGED ON 655, MARCH 4TH TO 5TH 2020. LOT. NO. 0063230 WAS MANUFACTURED ON LINE 9, APRIL 14 TO 17TH 2020 AND PACKAGED ON LINE 656, APRIL 17TH TO 18TH 2020. BASED ON THE MANUFACTURING DATES OF THE LOTS INVOLVED IT IS NOT POSSIBLE TO CONFIRM THE CAUSE AS MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: INITIAL REPORTER E-MAIL: UNKNOWN. 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 · 0

    IT WAS REPORTED THAT THE PACKAGE OF 8MM BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLES CONTAINED ONLY 6MM BD ULTRA-FINE PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY INFORMS US THAT IN THE PACKAGE WITH BD MICRO-FINE ULTRA NEEDLES OF LENGTH 8MM THERE ARE ONLY PEN NEEDLES OF LENGTH 6MM. THE EXACT NAME OF THE PEN NEEDLES INCLUDED IS: BD ULTRA-FINE PEN NEEDLE 0.25X 6MMLOT: 0063230EXPIRATION DATE: 2025-02-28."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGE OF 8MM BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLES CONTAINED ONLY 6MM BD ULTRA-FINE PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY INFORMS US THAT IN THE PACKAGE WITH BD MICRO-FINE ULTRA NEEDLES OF LENGTH 8MM THERE ARE ONLY PEN NEEDLES OF LENGTH 6MM. THE EXACT NAME OF THE PEN NEEDLES INCLUDED IS: BD ULTRA-FINE PEN NEEDLE 0.25X 6MM LOT: 0063230 EXPIRATION DATE: 2025-02-28".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223527 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8185560 00382903251056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown