BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 13182546 · Received January 6, 2022

    Report

    Report Number
    9616656-2021-01615
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 10, 2021
    Report Date
    February 17, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: 2/7/2022. H.6. INVESTIGATION: CUSTOMER RETURNED (4) USED 32GX4MM BD PEN NEEDLES FROM LOT# 1082132. THE CUSTOMER REPORTED THAT 5 PEN NEEDLES CLOGGED DURING INJECTION. THE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 EXHIBITED A BROKEN NON-PATIENT END (NPE) CANNULA, AND 2 EXHIBITED A BENT NPE CANNULA. THE REMAINING SAMPLE WAS TESTED FOR FLOW USING A TEST PEN INJECTOR AND WAS ABLE TO EXPEL PROPERLY. THE BENT AND BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THAT THE PEN NEEDLES WERE CLOGGED. SINCE ALL 4 PEN NEEDLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT OR BROKEN AFTER THE USER HANDLED THE PEN NEEDLES. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NANO¿ 2ND GEN PEN NEEDLE, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN/MEDICATION. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT 5 PEN NEEDLES CLOGGED DURING INJECTION. VERBATIM: CONSUMER REPORTED FOUND 5 PEN NEEDLES THAT CLOGGED DURING INJECTION. CONSUMER CALLED LILLY FIRST AND 2 DIFFERENT TIMES. HUMALOG USER FIRST TIME CALLED LILLY A FEW MONTHS AGO AND THEN AGAIN LAST WEEK LOT # 1082132 CATALOG# 320550 DATE OF EVENT 12/10/2021 = 3 PEN NEEDLES DATE OF EVENT UNKNOWN AS MUCH AS A FEW MONTHS AGO SAMPLE STATUS AWAITING SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD (B)(6) 2ND GEN PEN NEEDLE, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN/MEDICATION. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT 5 PEN NEEDLES CLOGGED DURING INJECTION. VERBATIM: CONSUMER REPORTED FOUND 5 PEN NEEDLES THAT CLOGGED DURING INJECTION. CONSUMER CALLED (B)(6) FIRST AND 2 DIFFERENT TIMES. HUMALOG USER FIRST TIME CALLED (B)(6) A FEW MONTHS AGO AND THEN AGAIN LAST WEEK LOT # 1082132, CATALOG# 320550 DATE OF EVENT (B)(6) 2021, 3 PEN NEEDLES DATE OF EVENT UNKNOWN AS MUCH AS A FEW MONTHS AGO SAMPLE STATUS AWAITING SAMPLE

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NANO¿ 2ND GEN PEN NEEDLE, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN/MEDICATION. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT 5 PEN NEEDLES CLOGGED DURING INJECTION. VERBATIM: CONSUMER REPORTED FOUND 5 PEN NEEDLES THAT CLOGGED DURING INJECTION. CONSUMER CALLED LILLY FIRST AND 2 DIFFERENT TIMES. HUMALOG USER FIRST TIME CALLED LILLY A FEW MONTHS AGO AND THEN AGAIN LAST WEEK. LOT # 1082132; CATALOG# 320550; DATE OF EVENT (B)(6) 2021 = 3 PEN NEEDLES; DATE OF EVENT UNKNOWN AS MUCH AS A FEW MONTHS AGO; SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571704 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 1082132 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown