BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 19824674 · Received July 25, 2024

    Report

    Report Number
    1911916-2024-00533
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 1, 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

    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.

    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

    ADDITIONAL INFORMATION RECEIVED WAS THERE ANY PATIENT HARM DUE TO THE ISSUE? THERE WAS NO PATIENT HARM DUE TO THIS ISSUE. MATERIAL #:305200; BATCH#:2172517. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE SHOT OFF SYRINGE AND DRUG WENT BLASTING OUT, WAS NOT ABLE TO INJECT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE SHOT OFF SYRINGE AND DRUG WENT BLASTING OUT, WAS NOT ABLE TO INJECT. PRODUCT#: 305200; LOT#: 2172517.

    Description of Event or Problem · 0

    MATERIAL #:305200 BATCH#:2172517 IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE SHOT OFF SYRINGE AND DRUG WENT BLASTING OUT, WAS NOT ABLE TO INJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303796 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