BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY

    MDR report key: 10457595 · Received August 26, 2020

    Report

    Report Number
    9616656-2020-00849
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 10, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205400
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) HAS BEEN USED AS A DEFAULT.  THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7052840, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2017-02-21, MEDICAL DEVICE LOT #: 7012659, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2017-01-12, MEDICAL DEVICE LOT #: 8045794, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-02-14. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND. RELATED COMPLAINT FOR INCORRECT/MISSING LABEL INFORMATION ON LOT #'S 7052840, 7012659 & 8045794. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, INCORRECT/MISSING LABEL INFORMATION) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. 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. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 PEN NDL 32 G 4 MM 5B XTW BULK US W/EXPIRY EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 OF 2. VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT EXPIRATION DATES FOR PEN NEEDLE SAMPLE PACKS. STATED HE HAS 5 SAMPLE PACKS WITH NO EXPIRATION DATE ON THEM. STATED HE COULD NOT FIND A COPYRIGHT DATE OR MANUFACTURE DATE AND HE COULD NOT REMEMBER IF THESE WERE FROM 2007/2008 OR 2017/2018. ADVISED CONSUMER THAT WITHOUT A MANUFACTURE OR COPYRIGHT DATE, UNABLE TO CONFIRM THE YEAR. ADVISED CONSUMER THESE COULD BE EXPIRED. LOT # 7052840, LOT # FOR 2 BOXES: 8045794, LOT # 8144503, LOT #7012659, CAT # FOR ALL PACKS: 320540.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922258 PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY HYPODERMIC NEEDLE SINGLE LUMEN FMI BECTON DICKINSON AND CO. 320540 SEE H10 00382903205400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other