BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 19483126 · Received June 7, 2024

    Report

    Report Number
    1911916-2024-00413
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 17, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    UNK
    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

    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 THERE WAS A LEAK BETWEEN THE NEEDLE AND 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 A PACKAGING BOX OF A DRUG LABELED AS 'IZERVAY.' NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305200, LOT 2082199. 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. WITHOUT THE ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL # 305200 LOT # 2082199 IT WAS REPORTED BY CUSTOMER THAT LEAK BETWEEN NEEDLE & SYRINGE, MEDICATION INADVERTENTLY RELEASE PRIOR TO TREATMENT. ADDITIONAL INFORMATION: PLEASE SEE MY RESPONSES BELOW. 1. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? I AM ACTIVELY TRYING TO VERIFY IF PICTURES ARE AVAILABLE. IF AVAILABLE, I WILL FORWARD THEM. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? BEFORE USE/ PRIOR TO TREATMENT. 3. DID THE REPORTED ISSUE HAVE ANY IMPACT ON THE PATIENT? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? NO PORTION OF THE PRODUCT WAS ADMINISTERED TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL # 305200 LOT # 2082199 IT WAS REPORTED BY CUSTOMER THAT LEAK BETWEEN NEEDLE & SYRINGE, MEDICATION INADVERTENTLY RELEASE PRIOR TO TREATMENT. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE REPORT STATES, "LEAK BETWEEN NEEDLE & SYRINGE, MEDICATION INADVERTENTLY RELEASE PRIOR TO TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258387 NEEDLE FILTER 19X1-1/2 TW NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 2082199 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown