BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 19547646 · Received June 17, 2024

    Report

    Report Number
    1911916-2024-00430
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 2363735. 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

    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. DEFECT INFECTION: ¿PJP OPHTHALMOLOGY TOGETHER WITH MEDINFO INFORMED QA IN (B)(6) 2024, THAT AN EYE CLINIC IN SWEDEN HAVE HAD A CLUSTER OF PATIENTS (9 PATIENTS) WITH SIGN OF INFECTION ( INTRAOCULAR INFLAMMATION) AFTER TREATMENT (PERFORMED DIFFERENT TIMES, DIFFERENT PATIENTS) WITH VABYSMO. ". NEITHER THE SAMPLE NOR ANY PHOTOGRAPHS ARE AVAILABLE. THIS IS A NOTIFICATION ONLY. NO INVESTIGATION IS CURRENTLY REQUESTED. HARM TO THE PATIENT NOT REPORTED.

    Description of Event or Problem · 0

    DEFECT INFECTION ¿PJP OPHTHALMOLOGY TOGETHER WITH MED INFO INFORMED QA IN 21 MAY 2024, THAT AN EYE CLINIC IN SWEDEN HAVE HAD A CLUSTER OF PATIENTS (9 PATIENTS) WITH SIGN OF INFECTION ( INTRAOCULAR INFLAMMATION) AFTER TREATMENT (PERFORMED DIFFERENT TIMES, DIFFERENT PATIENTS) WITH VABYSMO. " NEITHER THE SAMPLE NOR ANY PHOTOGRAPHS ARE AVAILABLE. THIS IS A NOTIFICATION ONLY. NO INVESTIGATION IS CURRENTLY REQUESTED. HARM TO THE PATIENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651302 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 2363735 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other