BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS INSULIN PEN NEEDLE

    MDR report key: 10269467 · Received July 14, 2020

    Report

    Report Number
    9616656-2020-00663
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 28, 2020
    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

    H.6. INVESTIGATION: TWO OPEN 32G X 4MM PEN NEEDLE CARTONS WITH ELEVEN SEALED POLYBAGS WERE RETURNED FROM LOT. NO. 0014205, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED CARTONS AND NO ISSUES WERE OBSERVED ON THE CARTONS. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED POLYBAGS AND A CREASE IN THE SEAL WAS OBSERVED ON FIVE POLYBAGS. ALL PEN NEEDLES IN THE POLYBAGS HAD A FULL SEAL. A LOOSE TEARDROP LABEL WAS ALSO OBSERVED IN THE SEAL OF ONE POLYBAG, NO EVIDENCE OF A SEAL BEING APPLIED TO THE TEARDROP LABEL WAS OBSERVED. NO ISSUES WERE OBSERVED WITH THE REMAINING FIVE POLYBAGS. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE ISSUE OF CREASING OCCURRED DURING THE PACKAGING STAGE OF THE PROCESS. THE MOST LIKELY ROOT CAUSE OF THE LOOSE TEARDROP LABEL IN THE SEAL OF THE POLYBAG WAS DUE TO A LOOSE LABEL BECOMING STUCK /STAKED TO A FINISHED PART ON THE ASSEMBLY LINE WHICH THEN BECAME LOOSE IN THE PACKAGING PROCESS AND GOT CAUGHT IN THE SEAL OF THE POLYBAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 42 BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE PACKAGING UNITS HAD WRINKLES IN THE SEALING, AND ANOTHER UNIT'S SEAL HAD "SHRUNK", WITH A PART OF THE TEAR DROP LABEL CAUGHT IN IT. THESE DEFECTS WERE NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "SIX POLYBAGS ARE SEALED WITH WRINKLES ON THE SEALING PART OF THE POLYBAGS. ESPECIALLY, ONE POLYBAG OUT OF SIX, THE SEALING PART OF THE POLYBAG IS PARTICULARLY SHRUNK, AND A PART OF THE TEAR DROP LABEL OF A PEN NEEDLE IS CAUGHT IN THE SEALING PART OF THE POLYBAG." "CUSTOMER REPORTED SEALING DEFECT OF SEVERAL POLYBAGS. ONE OF THEM WAS PARTICULARLY DEFECTIVE AND THE LABEL OF MFP WAS SEALED TOGETHER."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 42 BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE PACKAGING UNITS HAD WRINKLES IN THE SEALING, AND ANOTHER UNIT'S SEAL HAD "SHRUNK", WITH A PART OF THE TEAR DROP LABEL CAUGHT IN IT. THESE DEFECTS WERE NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SIX POLYBAGS ARE SEALED WITH WRINKLES ON THE SEALING PART OF THE POLYBAGS. ESPECIALLY, ONE POLYBAG OUT OF SIX, THE SEALING PART OF THE POLYBAG IS PARTICULARLY SHRUNK, AND A PART OF THE TEAR DROP LABEL OF A PEN NEEDLE IS CAUGHT IN THE SEALING PART OF THE POLYBAG." "CUSTOMER REPORTED SEALING DEFECT OF SEVERAL POLYBAGS. ONE OF THEM WAS PARTICULARLY DEFECTIVE AND THE LABEL OF MFP WAS SEALED TOGETHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732957 BD MICRO FINE PLUS INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0014205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other