BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 20844589 · Received December 4, 2024

    Report

    Report Number
    1911916-2024-00871
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    September 24, 2024
    Report Date
    December 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED THE SYRINGES WOULD NOT DEPRESS ONCE THE MEDICATION WAS DRAWN INTO THE SYRINGE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS FOUR NEEDLE ASSEMBLIES WITH THE PLASTIC SHIELDS ASSEMBLED TO SYRINGES. TWO SYRINGES HAVE THE RUBBER STOPPER AT THE 0.2ML GRADUATION MARK AND THE OTHER TWO SYRINGES HAVE THE RUBBER STOPPER AT THE 0.1ML GRADUATION MARK. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT 2020895. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305106 BATCH # 2020895 VERBATIM: MEDICAL INFORMATION RECEIVED A CALL FROM THE REPORTER TO REQUEST RETURN FOR 3 EYLEA VIALS. THE SYRINGES WOULD NOT DEPRESS ONCE THE MEDICATION WAS DRAWN INTO THE SYRINGE. NO ACTUAL ISSUE WITH THE MEDICATION ITSELF IN TERMS OF PTC. THE SYRINGE AND VIALS ARE ALL AVAILABLE FOR RETURN. NO PATIENTS MISSED A DOSE DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942381 NEEDLE 30X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 2020895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown