BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM (70 COUNT)

    MDR report key: 17222319 · Received June 28, 2023

    Report

    Report Number
    9616656-2023-00669
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201365
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 07-JUL-2023. H6: INVESTIGATION SUMMARY THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2116278 AND TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2200693, CAT. NO. 320136 ALONG WITH THREE PHOTOS. VISUAL EXAMINATION WAS CARRIED OUT THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ALL FIVE SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM (70 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE INJECTION NEEDLE WAS ATTACHED TO THE PEN, BUT NO CHEMICAL SOLUTION CAME OUT. NPE BEND WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM (70 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE INJECTION NEEDLE WAS ATTACHED TO THE PEN, BUT NO CHEMICAL SOLUTION CAME OUT. NPE BEND WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308538 BD MICRO-FINE ULTRA¿ PEN NEEDLES 32G X 4MM (70 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2200693 00382903201365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown