BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNTFILL

    MDR report key: 18154982 · Received November 16, 2023

    Report

    Report Number
    1911916-2023-00848
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    November 6, 2023
    Report Date
    March 6, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    00382903031290
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 220728. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, WE WERE UNABLE TO COMPLETE A THOROUGH SAMPLE ANALYSIS. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. IT IS POSSIBLE THAT THE STOPPER CONDITIONS (ASK YOUR SUPPLIER FOR MATERIAL CHANGES AS WELL AS RECOMMENDATIONS OF STORAGE IN CASE HUMIDITY AND/OR TEMPERATURE AFFECTS THE FRAGMENTATION OF THE RUBBER) AND THE HANDLING OF THE PRODUCT HAD A ROLE IN THE REPORTED INCIDENT. IF THE SAMPLE BECOMES AVAILABLE FOR RETURN, FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT. DEVICE PROBLEM CODE: A180104 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IV MEDICATION VIAL ACCESSED THROUGH RUBBER STOPPER BY BD BLUNT FILL NEEDLE. SMALL RED CONTAMINANT DRAWN UP INTO SYRINGE, SAME COLOUR AS THE VIAL STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912971 NEEDLE 18X1-1/2 BLUNTFILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 220728 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown