BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 3.3QT RED

    MDR report key: 10535126 · Received September 15, 2020

    Report

    Report Number
    2243072-2020-01422
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 22, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903054886
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT WAS REPORTED THAT THE PRODUCT WAS DAMAGED IN TRANSIT WITH NO FURTHER INVESTIGATION REQUIRED. THE DAMAGE OCCURRED WHILE WAITING TO BE SHIPPED AT AN INDIA WAREHOUSE. NOT A MANUFACTURING RELATED ISSUE. NO SUPPLIER INVESTIGATION IS APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL 3.3QT RED HAD MISSING LABEL INFORMATION. ADDITIONALLY, IT WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SHARPS CONTAINER WAS DAMAGED AND UNITS WERE MISSING LABELS. VERBATIM: REC'D THIS FROM SATURDAY EVENING FROM D.T AT FISHER CLINICAL REGARDING SHARPS CONTAINER 305488, LOT # 0090001. IS THIS A PRODUCT COMPLAINT OR SERVICE? DO I FORWARD THIS ON TO YOU? DO YOU WANT MORE INFORMATION FIRST? WITHIN FISHER CLINICAL SERVICES, WE HELP OUR COMPANY TO FULFILL ITS MISSION TO ENABLE OUR CUSTOMERS TO MAKE THE WORLD HEALTHIER, CLEANER AND SAFER BY CONTINUOUSLY IMPROVING THE QUALITY OF OUR PRODUCTS AND SERVICES AND BY ENSURING GLOBAL REGULATORY COMPLIANCE. PART OF THIS COMPLIANCE INCLUDES ADHERENCE TO SET STANDARDS WE SET AS A BUSINESS, REGARDING THE DISPOSITION AND USABILITY OF PRODUCT WITHIN OUR CLIENTS' CLINICAL TRIAL SETTINGS. THIS NOTIFICATION IS INTENDED TO ALERT YOU ON SOME QUALITY CONCERNS WE'VE NOTICED AS PART OF OUR POST-RECEIPT PROCESS, AND IS LISTED AS FOLLOWS: PN J9074 (DAMAGE INCLUDING STAINS/SMUDGES, CUTS, SCRATCHES ON INDIVIDUAL UNIT LABELING AND ALSO DAMAGED UNITS WITH NO LABELS ON INDIVIDUAL UNITS, I.E. UNITS MISSING LABELING) FOR BATCH 0090001 SHARPS CONTAINER WE ENCOURAGE YOUR COMPANY TO FURTHER INVESTIGATE THESE ABOVE ISSUES, AND PLEASE ADVISE IF THERE ARE ANY INTENDED PROCESS AND/OR MANUFACTURING CHANGES THAT YOU CAN COMMIT TO AS PART OF THIS NOTIFICATION. PLEASE ACKNOWLEDGE RECEIPT OF THIS NOTIFICATION VIA EMAIL RESPONSE, REPLYING ALL. THANK YOU FOR YOUR PARTNERSHIP IN THIS EFFORT, AND HELPING TO KEEP OUR CLIENTS (AND PATIENTS) SAFE."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL 3.3QT RED HAD MISSING LABEL INFORMATION. ADDITIONALLY, IT WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SHARPS CONTAINER WAS DAMAGED AND UNITS WERE MISSING LABELS VERBATIM: REC'D THIS FROM SATURDAY EVENING FROM (B)(4) AT FISHER CLINICAL REGARDING SHARPS CONTAINER 305488, LOT # 0090001. IS THIS A PRODUCT COMPLAINT OR SERVICE? DO I FORWARD THIS ON TO YOU? DO YOU WANT MORE INFORMATION FIRST? WITHIN FISHER CLINICAL SERVICES, WE HELP OUR COMPANY TO FULFILL ITS MISSION TO ENABLE OUR CUSTOMERS TO MAKE THE WORLD HEALTHIER, CLEANER AND SAFER BY CONTINUOUSLY IMPROVING THE QUALITY OF OUR PRODUCTS AND SERVICES AND BY ENSURING GLOBAL REGULATORY COMPLIANCE. PART OF THIS COMPLIANCE INCLUDES ADHERENCE TO SET STANDARDS WE SET AS A BUSINESS, REGARDING THE DISPOSITION AND USABILITY OF PRODUCT WITHIN OUR CLIENTS' CLINICAL TRIAL SETTINGS. THIS NOTIFICATION IS INTENDED TO ALERT YOU ON SOME QUALITY CONCERNS WE'VE NOTICED AS PART OF OUR POST-RECEIPT PROCESS, AND IS LISTED AS FOLLOWS: PN J9074 (DAMAGE INCLUDING STAINS/SMUDGES, CUTS, SCRATCHES ON INDIVIDUAL UNIT LABELING AND ALSO DAMAGED UNITS WITH NO LABELS ON INDIVIDUAL UNITS, I.E. UNITS MISSING LABELING) FOR BATCH 0090001 SHARPS CONTAINER. WE ENCOURAGE YOUR COMPANY TO FURTHER INVESTIGATE THESE ABOVE ISSUES, AND PLEASE ADVISE IF THERE ARE ANY INTENDED PROCESS AND/OR MANUFACTURING CHANGES THAT YOU CAN COMMIT TO AS PART OF THIS NOTIFICATION. PLEASE ACKNOWLEDGE RECEIPT OF THIS NOTIFICATION VIA EMAIL RESPONSE, REPLYING ALL. THANK YOU FOR YOUR PARTNERSHIP IN THIS EFFORT, AND HELPING TO KEEP OUR CLIENTS (AND PATIENTS) SAFE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001348 SHARPS COLL 3.3QT RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305488 0090001 00382903054886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other