BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 27X1-1/4 RB

    MDR report key: 18684857 · Received February 12, 2024

    Report

    Report Number
    1911916-2024-00076
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051367
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305136 AND LOT NUMBER 2021694. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (B)(4): 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. MATERIALS#: 305136, BATCH#: 2021694. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE SNAPPING OFF AT HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER REPORTS NEEDLE SNAPPING OFF AT HUB THIS HAS HAPPENED BEFORE HOWEVER ON (B)(6) 2024 STATES GIVING INJECTION TO PATIENT AND NEEDLE SNAPPED OFF IN PATIENT BUTTOCK AND SENT TO HOSPITAL. PRODUCT#: 305136. LOT#: 2021694.

    Description of Event or Problem · 0

    MATERIALS#: 305136. BATCH#: 2021694. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE SNAPPING OFF AT HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER REPORTS NEEDLE SNAPPING OFF AT HUB. THIS HAS HAPPENED BEFORE, HOWEVER ON (B)(6) 2024, STATES GIVING INJECTION TO PATIENT AND NEEDLE SNAPPED OFF IN PATIENT BUTTOCK AND SENT TO HOSPITAL. PRODUCT#: 305136. LOT#: 2021694.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465403 NEEDLE 27X1-1/4 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 2021694 30382903051367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention