BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 7503534 · Received May 10, 2018

    Report

    Report Number
    9616656-2018-00106
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE PHOTOS OF A 31G X 5MM PEN NEEDLE CARTON WERE RETURNED FROM LOT. NO. 7326749, CAT. NO. 325107. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND IT WAS OBSERVED THAT FOUR 31G X 8MM PEN NEEDLES FROM LOT. NO. 7052761 WERE MIXED IN WITH PEN NEEDLES FROM LOT. NO. 7326749. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: LOT. NO. 7326749 WAS MANUFACTURED BETWEEN 25TH TO 28TH JANUARY 2018 AND LOT. NO. 7052761 WAS MANUFACTURED BETWEEN 28TH TO 30TH MARCH 2017, THEREFORE THIS IS NOT MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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 BEFORE USE A BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE WAS FOUND WITH A LABELING ERROR AS "THE SHELF BOX OF 5MM NEEDLES CONTAINED 4 8MM NEEDLES". THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347403 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7326749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other