BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLE 4MM (5/32¿) 32G

    MDR report key: 9546909 · Received January 3, 2020

    Report

    Report Number
    9616656-2019-01299
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED FOUR (4) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, BRUISING AT THE INJECTION SITE AND HIGH GLUCOSE LEVEL AFTER INJECTION. ALL FOUR RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL FOUR HAD BENT NON-PATIENT END (NPE) CANNULAS, AND TWO HAD HOOKED PATIENT END (PE) CANNULA POINTS. THE TWO PEN NEEDLES WITH GOOD PE CANNULA POINTS WERE TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿- 0.0095¿): DATA: POINT (PE) OUTER DIAMETER (IN) LUBE SAMPLE 1, GOOD , 0.0092 , GOOD, SAMPLE 2, GOOD , 0.0092 , GOOD, NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE TWO TESTED PEN NEEDLES. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). SINCE ALL FOUR PEN NEEDLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS AND HOOKED PE CANNULA POINTS IS USER ERROR WHEN USING THE PEN NEEDLES. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NPE CANNULA, HOOKED PE CANNULA POINT). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION THE POSSIBLE ROOT CAUSE FOR THESE ISSUES (HOOKED PE CANNULA POINT, BENT NPE CANNULA) IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. SINCE THE TWO SAMPLES WITH HOOKED PE CANNULA POINTS HAD BEEN RETURNED AFTER USE, THE PROBABLE CAUSE OF THIS ISSUE IS USER ERROR WHILE USING THE PEN NEEDLES. IF THE USER REMOVES THE CANNULA SHIELD OBLIQUELY THEY MAY CAUSE THE CANNULA TO HOOK DURING THE SHIELD REMOVAL PROCESS. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLE 4MM (5/32¿) 32G HAS BEEN FOUND EXPERIENCING INABILITY TO DELIVER MEDICATION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE CLOGGED DURING INJECTION, BRUISING AT INJECTION SITE, AND ELEVATED GLUCOSE LEVEL AFTER INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, BRUISING AT THE INJECTION SITE AND HIGH GLUCOSE LEVEL AFTER INJECTION. PROBLEM OCCURRED ABOUT TWO MONTHS AGO, DATE UNKNOWN. CONSUMER DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION. LOT # 9099930. PRODUCT # 320122. EXP DATE 04-30-2024. INCIDENT DATE UNKNOWN. OCCURRENCE UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLE 4MM (5/32¿) 32G HAS BEEN FOUND EXPERIENCING INABILITY TO DELIVER MEDICATION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE CLOGGED DURING INJECTION, BRUISING AT INJECTION SITE, AND ELEVATED GLUCOSE LEVEL AFTER INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, BRUISING AT THE INJECTION SITE AND HIGH GLUCOSE LEVEL AFTER INJECTION. PROBLEM OCCURRED ABOUT TWO MONTHS AGO, DATE UNKNOWN. CONSUMER DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION. LOT #: 9099930, PRODUCT #: 320122, EXP DATE: 04-30-2024, INCIDENT DATE: UNKNOWN. OCCURRENCE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9323 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9099930 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other