BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA TWINPAK DEVICE

    MDR report key: 21915937 · Received April 27, 2025

    Report

    Report Number
    1911916-2025-00313
    Event Type
    Malfunction
    Date Received
    April 27, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 2, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903033904
    PMA / PMN Number
    K974006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. DEVICE EVALUATION: IT WAS REPORTED TWO BOXES HAVE THE SAME LOT NUMBER, BUT THE EXPIRATION DATE IS DIFFERENT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS TWO PACKAGING SHELF BOXES. ONE SHELF BOX HAS THE EXPIRATION DATE AS 2029-05-31 AND THE SECOND SHELF BOX LABEL HAS THE EXPIRATION DATE AS 2024-05-31. THIS CONDITION OCCURS IF THERE IS A TYPO WHEN ENTERING THE VARIABLE DATA. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303390, LOT 4142679. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE EVENT WILL BE SHARED WITH ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT HAS BEEN REPORTED THAT TWO BOXES SHARE THE SAME LOT NUMBER, YET THEIR EXPIRATION DATES DIFFER. TO ASSIST IN THE INVESTIGATION, OUR QUALITY TEAM RECEIVED TWO PHOTOGRAPHS FOR EVALUATION. ONE PHOTOGRAPH DEPICTS TWO PACKAGING SHELF BOXES: ONE WITH AN EXPIRATION DATE OF 2029-05-31, AND THE OTHER WITH AN EXPIRATION DATE OF 2024-05-31. THE SECOND PHOTOGRAPH SHOWS FIVE PACKAGING BLISTER TOP WEBS, ALL BEARING THE EXPIRATION DATE OF 2029-05-31. THIS DISCREPANCY MAY HAVE ARISEN DUE TO A TYPOGRAPHICAL ERROR DURING THE ENTRY OF VARIABLE DATA. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 303390, LOT 4142679. THE REVIEW DID NOT UNCOVER ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL PROCESSES AND FINAL INSPECTIONS ADHERED TO SPECIFICATION REQUIREMENTS. THIS EVENT WILL BE COMMUNICATED TO ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND PHOTO SAMPLE ANALYSIS, THE SYMPTOM REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 303390. BATCH # 4142679. IT WAS REPORTED BY THE CUSTOMER THAT THE TWIN PAK NEEDLES, EACH HAVE THE SAME LOT# BUT THE OUTDATE IS VERY CLEARLY NOT THE SAME. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I NEED TO BRING THIS ISSUE TO YOUR ATTENTION. THE PRODUCT IN THE PICTURE, (B)(6) TWIN PAK NEEDLES, EACH HAVE THE SAME LOT# BUT THE OUTDATE IS VERY CLEARLY NOT THE SAME. COULD YOU PLEASE ALERT BD AND HAVE THEM PROVIDE US SOME CLARIFICATION AS TO THE CORRECT DATE? I HAVE 9 BOXES IN THE STOREROOM WITH THE EARLIER OUTDATE, AND PROBABLY. ITEM - 303390. LOT - 4142679.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289533 CANNULA TWINPAK DEVICE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4142679 00382903033904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown