BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23X1-1/2 RB TW

    MDR report key: 20544379 · Received October 28, 2024

    Report

    Report Number
    1911916-2024-00765
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 13, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051947
    PMA / PMN Number
    K021475
    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

    FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF (B)(4) AND THE COMPLAINT WILL BE CANCELLED. THE ASSOCIATED MDR WILL BE VOID.

    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

    FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF (B)(4) AND THE COMPLAINT WILL BE CANCELLED. THE ASSOCIATED MDR WILL BE VOID.

    Description of Event or Problem · 0

    MATERIAL #: 305194; BATCH#: 3320231. IT WAS REPORTED BY CUSTOMER THAT PATIENT REPORTED TO SPECIALTY PHARMACY ON (B)(6) 2024. PATIENT OPENED SECURE CAP FROM DILUENT SYRINGE AND ATTACHED NEEDLE. UPON PUSHING DOWN ON PLUNGER THE LIQUID LEAKED OUT FROM THE JUNCTION BETWEEN THE SYRINGE THE NEEDLE. PATIENT EXPERIENCED THIS SAME ISSUE 2 MORE TIMES BEFORE SHE GOT ONE TO WORK. GATTEX DOSE NOT MISSED. PATIENT HAS BEEN TAKING GATTEX FOR OVER 7 YEARS. THIS ISSUE HAS NOT OCCURRED AGAIN SINCE THE DAY THIS HAPPENED THIS MONTH. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED EXTERNAL EVALUATION IS REQUIRED FOR PR# (B)(4) ¿ LEAKING. PRODUCT: GATTEX ; COMPONENT DESCRIPTION: BD SYRINGE: NEEDLE 23X 1-1/2; BD CATALOGUE: 3320231 EXP. 01/2029; INV DUE: (B)(6) 2024. REPORT RECEIVED FROM PV ON 11OCT2024: PATIENT REPORTED TO SPECIALTY PHARMACY ON (B)(6) 2024. PATIENT OPENED SECURE CAP FROM DILUENT SYRINGE AND ATTACHED NEEDLE. UPON PUSHING DOWN ON PLUNGER THE LIQUID LEAKED OUT FROM THE JUNCTION BETWEEN THE SYRINGE THE NEEDLE. PATIENT EXPERIENCED THIS SAME ISSUE 2 MORE TIMES BEFORE SHE GOT ONE TO WORK. GATTEX DOSE NOT MISSED. PATIENT HAS BEEN TAKING GATTEX FOR OVER 7 YEARS. THIS ISSUE HAS NOT OCCURRED AGAIN SINCE THE DAY THIS HAPPENED THIS MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166795 NEEDLE 23X1-1/2 RB TW NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3320231 30382903051947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown