BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA TWINPAK DEVICE

    MDR report key: 19895170 · Received August 2, 2024

    Report

    Report Number
    1911916-2024-00563
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 14, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903033904
    PMA / PMN Number
    K974006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 10581293 FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE WAS A MISMATCH IN THE EXPIRATION DATE. TO AID IN THE INVESTIGATION, ONE SHELF BOX AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE SHELF BOX HAS A GREEN LABEL WITH THE FOLLOWING INFORMATION: LOT 4142679, EXPIRATION DATE 2029-05-31. UNDER THIS GREEN LABEL THERE IS A WHITE LABEL WITH THE EXPIRATION DATE OF 2024-05-31. INSIDE THE SHELF BOX THERE ARE ONE HUNDRED SEALED PACKAGING BLISTERS WITH THE EXPIRATION DATE OF 2029-05-31. THE TWO PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. NO OTHER DEFECTS OR DISCREPANCIES WERE OBSERVED. THIS DEFECT COULD OCCUR IF ADDITIONAL LABELS WERE NEEDED AND PRINTED MANUALLY WITH THE INCORRECT EXPIRATION DATE. 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 DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #:303390. BATCH#:4142679. IT WAS REPORTED BY CUSTOMER THAT THERE IS A MISMATCH IN EXPIRY DATE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE OPEN A QUALITY COMPLAINT FOR THIS BD PRODUCT AT COREWELL HEALTH. ALSO, PLEASE CONFIRM THE OFFICIAL EXPIRATION DATE OF THE LOT IN QUESTION. HERE ARE THE RELEVANT EVENT AND PRODUCT DETAILS: EVENT DATE: 7-30-2024. EVENT LOCATION: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX EVENT DESCRIPTION: ¿PRODUCT WITH LOT# 4142679 HAS A 5-31-29 EXPIRATION DATE PRINTED ON THE OUTER-MOST CASE. THE 10 BOXES INSIDE THE CASE HAVE A 5-31-24 EXPIRATION DATE, AND THE INDIVIDUAL CANNULAS HAVE A 5-31-29 EXPIRATION DATE.¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY TO MY KNOWLEDGE. PRODUCT NAME: ITM-1138902 - DEVICE TWIN PAK DUAL CANNULA. PRODUCT REF: 303390. LOT NUMBER: 4142679. BD CUSTOMER ACCOUNT NUMBER: (B)(4). ACTUAL PRODUCT INVOLVED IS AVAILABLE FOR RETURN FOR EVALUATION PURPOSES ¿ PLEASE SEND SHIPPING LABEL.

    Description of Event or Problem · 0

    MATERIAL #:303390 BATCH#:4142679 IT WAS REPORTED BY CUSTOMER THAT THERE IS A MISMATCH IN EXPIRY DATE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED PLEASE OPEN A QUALITY COMPLAINT FOR THIS BD PRODUCT AT (B)(6). ALSO, PLEASE CONFIRM THE OFFICIAL EXPIRATION DATE OF THE LOT IN QUESTION. HERE ARE THE RELEVANT EVENT AND PRODUCT DETAILS: EVENT DATE: 7-30-2024 EVENT LOCATION: EVENT DESCRIPTION: ¿PRODUCT WITH LOT# 4142679 HAS A 5-31-29 EXPIRATION DATE PRINTED ON THE OUTER-MOST CASE. THE 10 BOXES INSIDE THE CASE HAVE A 5-31-24 EXPIRATION DATE, AND THE INDIVIDUAL CANNULAS HAVE A 5-31-29 EXPIRATION DATE.¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY TO MY KNOWLEDGE. PRODUCT NAME: ITM-1138902 - DEVICE TWIN PAK DUAL CANNULA PRODUCT REF: 303390 LOT NUMBER: 4142679 BD CUSTOMER ACCOUNT NUMBER: (B)(6) ACTUAL PRODUCT INVOLVED IS AVAILABLE FOR RETURN FOR EVALUATION PURPOSES ¿ PLEASE SEND SHIPPING LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385180 CANNULA TWINPAK DEVICE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4142679 00382903033904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown