BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT

    MDR report key: 16545993 · Received March 15, 2023

    Report

    Report Number
    3014704491-2023-00053
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    UDI-DI
    80382903206182
    PMA / PMN Number
    K142336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 22-MAR-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (50) UNOPENED 32G 4MM LOOSE PEN NEEDLES FROM THE LOT# 2123560. IT WAS REPORTED BY THE CONSUMER THAT NEEDLE APPEARS LONGER. ALL THE RETURNED SAMPLES VISUALLY EXAMINED AND OBSERVED NO ISSUES. THE RETURNED SAMPLES(30) WERE MEASURED FOR CANNULA LENGTH USING COMPARATOR AND ALL THE NEEDLES CANNULA LENGTH WAS MEASURED WITHIN THE SPECIFIED ACCEPTANCE LIMITS (4MM: 3.8MM TO 4.6MM). 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. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT THE CANNULA WAS TOO LONG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE NEEDLE TO APPEAR LONGER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT THE CANNULA WAS TOO LONG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE NEEDLE TO APPEAR LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757915 RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 2123560 80382903206182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown