BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 21710714 · Received March 27, 2025

    Report

    Report Number
    1911916-2025-00248
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLE CAME OFF THE SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305200 AND LOT NUMBER 2172517. 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. 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

    MATERIAL #305200 BATCH #2172517. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE CAME OFF OF SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. "NEEDLE CAME OFF OF SYRINGE". LOT#: 2172517. 19MAR2025 - A REPORT WAS RECEIVED FROM ASTELLAS SAFETY IN THE PRODUCT COMPLAINTS EMAIL BOX REGARDING IZERVAY, THE REPORT STATES, "DRUG WAS DRAWN UP USING STERILE TECHNIQUE, DURING PRIMING, NEEDLE CAME OFF OF SYRINGE AND MEDICATION EJECTED FROM SYRINGE", PER THE BREAKAGE AND SPOILAGE REPLACEMENT FORM, THE SERIAL NUMBER IS (B)(6). 19MAR2025 - EMAIL NOTIFICATION SENT TO SAFETY, 19MAR2025 - REFERENCE THE ATTACHED REPORTS REGARDING THE LOT QUERY AND SIMILAR DEFECT QUERY, 19MAR2025 - PER THE ASTELLAS COC, SYRINGE LOTS 3027073 AND 3027085 WERE USED IN IZERVAY KIT LOT T16240047A, 19MAR2025 - INVESTIGATION REQUEST SENT TO BD FOR SYRINGE LOTS 3027073 AND 3027085, IZERVAY KIT LOT T16240047A. 20MAR2025 - CALLED THE EYE CLINIC, SPOKE TO A REPRESENTATIVE, NEITHER THE HCP NOR OFFICE MANAGER WERE AVAILABLE, LEFT A MESSAGE FOR THE OFFICE REQUESTING A CALL BACK TO VERIFY WHAT NEEDLE (FILTER OR ADMINISTRATION) CAME OFF THE SYRINGE. 20MAR2025 - IT WAS DETERMINED THAT SINCE IT WAS UNKNOWN WHAT NEEDLE CAME OFF THE SYRINGE, AN INVESTIGATION INTO THE NEEDLE COMPONENT WOULD BE SUBMITTED, 20MAR2025 - INVESTIGATION REQUEST SENT TO BD FOR THE NEEDLE COMPONENT, LOT # 2172517, CUSTOMER RESPONDED ON (B)(6). 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS NOT ADMINISTERED TO THE PATIENT. THERE WAS NO REPORTED HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME TO THE PATIENT OR HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470884 NEEDLE FILTER 19X1-1/2 TW NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 2172517 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown