BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    31 G X 8 MM BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE

    MDR report key: 7652984 · Received June 29, 2018

    Report

    Report Number
    9616656-2018-00134
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 11, 2018
    Report Date
    August 8, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (157) LOOSE LANCETS, NOT USED, IN AN OPEN BOX FOR ULTRA FINE SHORT PEN NEEDLES (8MM X 31G, LOT#: 7241632). CONSUMER REPORTED THAT 197 GREEN ULTRA-FINE LANCETS WERE MIXED INTO THE BOX WITH THE PEN SHORT NEEDLES. ALL RETURNED LANCETS WERE EXAMINED AND COUNTED. THERE WERE 157 UNUSED LANCETS RECEIVED, LOOSE IN THE OPENED PEN NEEDLE BOX. SINCE THE BOX WAS ALREADY OPENED, IT COULD NOT BE DETERMINED IF THE LANCETS WERE MIXED WITH PEN NEEDLES AT THE MANUFACTURING SITE. NO PEN NEEDLES WERE RECEIVED AND THE BOX WAS NOT SEALED; HENCE, THE ALLEGED DEFECT COULD NOT BE CONFIRMED. 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. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE WAS MIXED WITH OTHER PRODUCTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 THE BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE WAS MIXED WITH OTHER PRODUCTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491686 31 G X 8 MM BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7241632 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other