BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLES

    MDR report key: 15999646 · Received December 16, 2022

    Report

    Report Number
    9616656-2022-01369
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 26, 2022
    Report Date
    January 20, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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: 05-JAN-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (5) 8MM, 31G PEN NEEDLES (1 OPEN WITHOUT THE TEAR DROP LABEL OR INNER SHIELD, 4 SEALED) FROM LOT # 2033589. CUSTOMER STATES THAT THE NEEDLE BROKE IN THE PET. ALL RETURNED PEN NEEDLES WERE EXAMINED AND THE OPEN SAMPLE EXHIBITED A BROKEN PATIENT END OF THE CANNULA. SEE ATTACHED PHOTO. MICROSCOPIC EXAMINATION OF BOTH FRACTURED ENDS ON THE SAMPLES REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS, CRACKED EPOXY AND TUBING OVALITY, ALSO KNOWN AS A DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION. WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RESTRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE EPOXY MADE THIS OBSERVATION MORE APPARENT. NO ISSUES WERE OBSERVED ON THE SEALED SAMPLES. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT IS USER RELATED AS THE PATIENT END OF THE CANNULA LIKELY BROKE BY THE BENDING/RESTRAIGHTENING MODE OF FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE EXPERIENCED THE CANNULA BREAKING OFF. X-RAY WAS PERFORMED BUT UNABLE TO LOCATE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED NEEDLE BREAK IN PET. CONSUMER STATED, AFTER GIVING HIS DOG INSULIN, HE NOTICED THE PATIENT END WAS MISSING. STATED, IT BROKE OFF IN THEIR DOG STATED, TOOK DOG FOR XRAY BUT NEEDLE WAS NOT LOCATED..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE EXPERIENCED THE CANNULA BREAKING OFF. X-RAY WAS PERFORMED BUT UNABLE TO LOCATE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED NEEDLE BREAK IN PET. CONSUMER STATED, AFTER GIVING HIS DOG INSULIN, HE NOTICED THE PATIENT END WAS MISSING. STATED, IT BROKE OFF IN THEIR DOG STATED, TOOK DOG FOR XRAY BUT NEEDLE WAS NOT LOCATED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201949 BD ULTRA-FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2033589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other