BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 17212345 · Received June 27, 2023

    Report

    Report Number
    9616656-2023-00651
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 2, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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: 04-AUG-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED 78 UNOPENED 32G 4MM PRO LOOSE PEN NEEDLES FROM THE LOT# 2221279, REPORTING CLOG AND HARM. ALL THE RETURNED SAMPLES VISUALLY EXAMINED AND OBSERVED NO ISSUES. 30 PEN NEEDLES WERE TESTED FOR CLOG AND OBSERVED NO ISSUES WITH FLOW. THE RETURNED SAMPLES WERE INSPECTED TO ENSURE THAT USING THEM WAS AS LEAST HARMFUL AS INTENDED. THE OUTER DIAMETERS OF THESE NEEDLES WERE MEASURED. ALL OF THE NEEDLES WERE MEASURED WITHIN ACCEPTABLE OUTER DIAMETERS FOR 32 GAUGE NEEDLES (0.0090 IN TO 0.0095 IN). THE INTEGRITY OF EACH NEEDLE POINT WAS INSPECTED AND NO DEFECTS WERE FOUND. NO DEBRIS WAS FOUND AT THE TIP OF ANY OF THE NEEDLES. FLOUR WAS APPLIED TO THE NEEDLE'S CANNULAS TO ENSURE THAT LUBRICANT WAS PRESENT. SUFFICIENT LUBRICANT WAS FOUND ON ALL SAMPLES. HENCE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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 SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5-6 TIEMS THE BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO DELIVER MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED HE HAS TO STICK HIMSELF 5 OR 6 TIMES TO COMPLETE ONE INJECTION STATED, INSULIN WILL STOP FLOWING BEFORE HIS SHOT IS COMPLETE STATED, DOES OT PRIME PRIOR TO INJECTION STATED, HE THERE'S BLEEDING AS A RESULT FROM STICKING HIMSELF MULTIPLE TIMES DID NOT SEEK MEDICAL STATED, THE PATIENT END WILL BEND WHEN TAKING INJECTION. DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5-6 TIMES THE BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO DELIVER MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED HE HAS TO STICK HIMSELF 5 OR 6 TIMES TO COMPLETE ONE INJECTION. STATED, INSULIN WILL STOP FLOWING BEFORE HIS SHOT IS COMPLETE. STATED, DOES OT PRIME PRIOR TO INJECTION. STATED, HE THERE'S BLEEDING AS A RESULT FROM STICKING HIMSELF MULTIPLE TIMES. DID NOT SEEK MEDICAL. STATED, THE PATIENT END WILL BEND WHEN TAKING INJECTION. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013049 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 2221279 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown