BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 11457331 · Received March 10, 2021

    Report

    Report Number
    9616656-2021-00228
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 38 BD ULTRA-FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION, AND EXPERIENCED A CANNULA THAT BROKE OFF/PULLED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HAVING 37 PEN NEEDLES THAT DO NOT WORK. STATED NO MEDICATION COMES OUT OF THE PEN NEEDLES DURING INJECTIONS. CONSUMER STATED HE HAD THIS ISSUE WITH A PREVIOUS BOX AS WELL. LOT # 0168008. CAT # 320144. DATE OF EVENT: UNKNOWN. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2021-03-02. G.10 IMDRF ANNEX A CODES: A140801, A0401. H.3. INVESTIGATION CODE(S): B01, B14. H.3. FINDINGS CODE(S): C070601, C070603. H.3. INVESTIGATION FINDINGS CODE: D11. H.3. COMPONENT CODE(S): G04019. H.6 INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: CUSTOMER RETURNED (6) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 0168008. CUSTOMER STATES THAT NO MEDICATION COMES OUT OF THE PEN NEEDLE DURING INJECTION. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 2 OUT OF 6 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA. ALL REMAINING SAMPLES EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. BOTH OF THESE ISSUES COULD PREVENT INSULIN FROM PROPERLY FLOWING THROUGH THE CANNULA. 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 AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT AND BROKEN NON PATIENT END OF THE CANNULA) 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 IS USER RELATED. THE NON PATIENT END OF THE CANNULA BENT AND BROKE DURING USE OF THE PRODUCT BY THE CUSTOMER. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 38 BD ULTRA-FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION, AND EXPERIENCED A CANNULA THAT BROKE OFF/PULLED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HAVING 37 PEN NEEDLES THAT DO NOT WORK. STATED NO MEDICATION COMES OUT OF THE PEN NEEDLES DURING INJECTIONS. CONSUMER STATED HE HAD THIS ISSUE WITH A PREVIOUS BOX AS WELL. LOT # 0168008. CAT # 320144. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0168008, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: 2020-06-16. MEDICAL DEVICE LOT #: 0231141, MEDICAL DEVICE EXPIRATION DATE: 2025-08-31, DEVICE MANUFACTURE DATE: 2020-08-18.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 39 BD ULTRA-FINE" PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HAVING 37 PEN NEEDLES THAT DO NOT WORK. STATED NO MEDICATION COMES OUT OF THE PEN NEEDLES DURING INJECTIONS. CONSUMER STATED HE HAD THIS ISSUE WITH A PREVIOUS BOX AS WELL. LOT # 0168008, CAT # 320144, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349911 BD ULTRA-FINE PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1