BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PEN NEEDLE

    MDR report key: 10423139 · Received August 18, 2020

    Report

    Report Number
    2243072-2020-01270
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    August 14, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    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. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. REPORTED CATALOG AND LOT NUMBERS: THERE WERE REPORTED CATALOG AND LOT NUMBERS. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE CATALOG #: 221031. MEDICAL DEVICE LOT #: 7283966. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO AN UNKNOWN LOT NUMBER FOR INCORRECT/MISSING LABEL INFORMATION. A REVIEW OF ALL RISK MANAGEMENT DOCUMENTS FOR THE PRODUCT FAMILY OF THE DEVICE INVOLVED IN THIS COMPLAINT (PEN NEEDLE, INCORRECT/MISSING LABEL INFORMATION), WAS PERFORMED AND IT WAS DETERMINED THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT WAS CAPTURED AND ADDRESSED INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK DUE TO AN UNKNOWN LOT NUMBER FOR INCORRECT/MISSING LABEL INFORMATION. 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 6 UNSPECIFIED BD¿ PEN NEEDLES WERE MISSING THE EXPIRATION DATES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:UNKNOWN (REPORTED 221031) BATCH NO:UNKNOWN (REPORTED 7283966). IT WAS REPORTED THAT THE CONSUMER CALLED STATING SHE HAS SIX SAMPLE PACKS OF THE BD ULTRA-FINE PEN NEEDLES WITH NO EXPIRATION DATE. VERBATIM: CONSUMER CALLED STATING SHE HAS 6 SAMPLE PACKS OF THE BD ULTRA-FINE PEN NEEDLES WITH NO EXPIRATION DATE. STATED SHE DOES NOT KNOW WHEN THEY EXPIRE. STATED THE BOX SAYS TRADEMARK DATE OF 2016. ADVISED CONSUMER THAT BD PRODUCTS ARE TESTED FOR 5 YEARS. FURTHER ADVISED THAT IF THESE SAMPLES ARE FROM 2017 THEY WOULD STILL BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883079 UNSPECIFIED BD PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other