BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 13546050 · Received February 16, 2022

    Report

    Report Number
    9616656-2022-00190
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    February 4, 2022
    Report Date
    April 25, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0231155. MEDICAL DEVICE EXPIRATION DATE: 08/31/2025. DEVICE MANUFACTURE DATE: 08/18/2020. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0231155. MEDICAL DEVICE EXPIRATION DATE: 08/31/2025. DEVICE MANUFACTURE DATE: 08/18/2020. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 24-FEB-2022. H.6. INVESTIGATION: CUSTOMER RETURNED 5 UNOPENED 4MM, 32 GAUGE NANO PRO PEN NEEDLES FROM LOT 1082129. VISUAL INSPECTION OF THE AVAILABLE PEN NEEDLES FOUND A FOREIGN MATERIAL ON THE NEEDLE IN 3 OF 5 PEN NEEDLES RETURNED DESPITE THE PEN NEEDLES NOT BEING USED PRIOR TO INSPECTION. NO OTHER DEFECTS WERE OBSERVED. ALL OF THE NEEDLES WERE MEASURED AT 0.0092 IN, WHICH IS WITHIN ACCEPTABLE OUTER DIAMETERS FOR 32 GAUGE NEEDLES (0.0090 IN TO 0.0095 IN). THE INTEGRITY OF THE NEEDLE POINTS WERE INSPECTED AND NO DEFECTS WERE FOUND. HOWEVER, THE MATERIAL PRESENT ON THE NEEDLES WOULD INTERFERE WITH REGULAR USE. 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 SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SKIN IRRITATION DUE TO THE PRESENCE OF FOREIGN MATERIAL ON THE NEEDLES. AS PER REQUEST, FTIR ANALYSIS WAS COMPLETED ON THE MATERIAL OBSERVED ON THE PATIENT END OF THE CANNULA. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BOXES OF BD NANO¿ 2ND GEN PEN NEEDLES HAD INSUFFICIENT CANNULA LENGTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CONSUMER IS GETTING A BUBBLE UNDER THE SKIN AT INJECTION SITE AND RED MARKS."

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BOXES OF BD NANO¿ 2ND GEN PEN NEEDLES HAD INSUFFICIENT CANNULA LENGTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CONSUMER IS GETTING A BUBBLE UNDER THE SKIN AT INJECTION SITE AND RED MARKS."

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BOXES OF BD NANO¿ 2ND GEN PEN NEEDLES HAD INSUFFICIENT CANNULA LENGTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CONSUMER IS GETTING A BUBBLE UNDER THE SKIN AT INJECTION SITE AND RED MARKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793287 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 UNKNOWN 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown