BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 19825941 · Received July 25, 2024

    Report

    Report Number
    1911916-2024-00541
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 11, 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

    PR (B)(4) FOLLOW UP 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. 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.

    Description of Event or Problem · 0

    MATERIAL #: 305200. BATCH#: 2172517. IT WAS REPORTED BY CUSTOMER THAT FILTER NEEDLE CONTAMINATED WHILE DRAWING UP MEDICATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? THERE WAS NO ADVERSE EVENT OR INJURY, SERIOUS OR OTHERWISE REPORTED REGARDING THE PATIENT OR THE HEALTHCARE PROFESSIONAL. PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. THERE WAS NO IMPACT TO THE PATIENT AS IT WAS REPORTED THAT NO PORTION OF THE PRODUCT WAS ADMINISTERED TO THE PATIENT. MATERIAL #: 305200. BATCH#: 2172517. IT WAS REPORTED BY CUSTOMER THAT FILTER NEEDLE CONTAMINATED WHILE DRAWING UP MEDICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE REPORT STATES, "FILTER NEEDLE CONTAMINATED WHILE DRAWING UP MEDICATION." PRODUCT#: 305200. LOT#: 2172517.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354352 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