BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 18958538 · Received March 22, 2024

    Report

    Report Number
    1911916-2024-00205
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    March 13, 2024
    Report Date
    March 29, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305200 AND LOT NUMBER 2082199. 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

    PR (B)(4): 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

    ADDITIONAL INFORMATION RECEIVED: MATERIAL#; 305200 , BATCH#: 2082199. IT WAS REPORTED BY THE CUSTOMER THAT WHEN MEDICATION WAS DRAWN UP, IT LEAKED FROM THE FILTER NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN MEDICATION WAS DRAWN UP, IT LEAKED FROM THE FILTER NEEDLE. PRODUCT DESCRIPTION - NEEDLE FILTER 19X1 - 1/2 TW. PRODUCT NUMBER - 305200. LOT NUMBER - 2082199. ADDITIONAL INFORMATION RECEIVED ON 18-MAR-2024 DO YOU HAVE PHOTOS SHOWING THE REPORTED ISSUE? WE DO NOT HAVE PHOTOS OF THE COMPLAINT SAMPLE IS THE PRODUCT AVAILABLE TO SEND BACK TO US FOR AN EVALUATION? UNKNOWN. DID THE EVENT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. UNKNOWN. PLEASE PROVIDE DATE OF EVENT- MARCH 13, 2024.

    Description of Event or Problem · 0

    MATERIAL#; 305200. BATCH#: 2082199. IT WAS REPORTED BY THE CUSTOMER THAT WHEN MEDICATION WAS DRAWN UP, IT LEAKED FROM THE FILTER NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WHEN MEDICATION WAS DRAWN UP, IT LEAKED FROM THE FILTER NEEDLE PRODUCT DESCRIPTION - NEEDLE FILTER 19X1 - 1/2 TW. PRODUCT NUMBER - 305200. LOT NUMBER - 2082199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559176 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