BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 15234876 · Received August 16, 2022

    Report

    Report Number
    9616656-2022-00857
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    July 21, 2022
    Report Date
    August 31, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H6: INVESTIGATION SUMMARY TWO PHOTOS OF A 32G X 4MM PEN NEEDLE WERE RETURNED FROM LOT. NO. 1012823, CAT. NO. 320477. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND NO ISSUES WERE OBSERVED. 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 PHOTOS RETURNED AND THE FACT NO PHYSICAL SAMPLE WAS RETURNED NO FURTHER INVESTIGATION COULD BE CARRIED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE EXPERIENCED PEN NEEDLE BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY FATHER USES THE BD NEEDLES ULTRA FINES 0.23*4MM FOR LANTUS INSULIN. YESTERDAY MORNING WHEN HE WAS USING THE NEEDLE FOR HIS INSULIN DOSE HE FOUND OUT THAT NEEDLE IS MISSING AFTER INJECTING. NOW WE ARE CONFUSED WHETHER IT IS IN THE SKIN OR FELL DOWN ON THE FLOOR. WE WENT TO THE SURGEON AND CHECKED AND FOUND OUT NOTHING. HE ALSO RECOMMENDED X RAYS AND CT SCANS. HOWEVER WE DIDN'T FIND THE CONCLUSIVE EVIDENCE YET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE EXPERIENCED PEN NEEDLE BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY FATHER USES THE BD NEEDLES ULTRA FINES 0.23*4MM FOR LANTUS INSULIN. YESTERDAY MORNING WHEN HE WAS USING THE NEEDLE FOR HIS INSULIN DOSE HE FOUND OUT THAT NEEDLE IS MISSING AFTER INJECTING. NOW WE ARE CONFUSED WHETHER IT IS IN THE SKIN OR FELL DOWN ON THE FLOOR. WE WENT TO THE SURGEON AND CHECKED AND FOUND OUT NOTHING. HE ALSO RECOMMENDED X RAYS AND CT SCANS. HOWEVER WE DIDN'T FIND THE CONCLUSIVE EVIDENCE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543259 BD ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1012823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention