BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VIVA¿ PEN NEEDLE

    MDR report key: 13715709 · Received March 9, 2022

    Report

    Report Number
    9616656-2022-00280
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 24, 2022
    Report Date
    May 20, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1243868 D4: MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026 H4: DEVICE MANUFACTURE DATE: 31-AUG-2021 H6: INVESTIGATION SUMMARY THREE PHOTOS WERE RETURNED OF TWO OPEN PEN NEEDLES AND ONE OPEN CARTON FROM LOT. NO. 1243868, CAT. NO. 320425. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND A BROKEN NON PATIENT END OF CANNULA AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED. AS NO PHYSICAL SAMPLES WERE RETURNED NO FUNCTIONALITY TEST CAN BE CARRIED OUT. 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 AND THE FACT NO PHYSICAL SAMPLES WERE RETURNED FOR INVESTIGATION THIS CANNOT BE CONFIRMED TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 2 BD VIVA¿ PEN NEEDLES WERE NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROBLEM IS THAT 2 OUT OF 3 NEEDLES THAT I USE DO NOT FIT ONTO THE PENS PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 2 BD VIVA¿ PEN NEEDLES WERE NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROBLEM IS THAT 2 OUT OF 3 NEEDLES THAT I USE DO NOT FIT ONTO THE PENS PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758381 BD VIVA¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1243868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown