BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23X1-1/2 RB

    MDR report key: 20722618 · Received November 19, 2024

    Report

    Report Number
    1911916-2024-00817
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    November 16, 2024
    Report Date
    November 26, 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
    003

    Narratives

    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305194 AND LOT NUMBER 3320231. 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.

    Description of Event or Problem · 0

    MATERIALS: 305194 BATCH#: 3320231. REPORT RECEIVED FROM PV ON 23OCT2024: PATIENT REPORTED NEEDLE WOULD BREAK FOR RECONSTITUTION NEEDLES SOMETIMES WHEN SHE ENTERED INTO VIAL AND ALSO CAP FOR DOSING NEEDLES ARE TOO TIGHT SOMETIMES AND HARD TO PULL OFF WHICH SHE WOULD THEN USE FORCE OR PLIER TOOL TO PULL CAP OFF AND IT WOULD BREAK AS WELL. PT DID NOT HAVE BOX TO PROVIDE LOT NUMBER. PRODUCT: GATTEX SAMPLE / PHOTO AVAILABILITY: NO SAMPLE OR PICTURES PROVIDED. AE: NO AE REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307482 NEEDLE 23X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3320231 30382903051947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown