BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 20280475 · Received September 23, 2024

    Report

    Report Number
    1911916-2024-00689
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    K941562
    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

    (B)(4). FOLLOW UP. IT WAS REPORTED THE BLISTER WAS UNSEALED IN AN UNOPENED KIT. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A PACKAGING BOX LABELED AS 'ASTELLA PHARMACEUTICAL IZERVAY.' NEXT TO THE PACKAGING BOX THERE ARE TWO NEEDLE ASSEMBLY PACKAGING BLISTERS LABELED AS 'EXEL.' NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305200, LOT 2172517. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    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

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305200, BATCH#: 2172517. IT WAS REPORTED BY CUSTOMER THAT NOT SURE WHO I NEED TO LET KNOW ABOUT THIS BUT ABOUT THIS SAMPLE IZERVAY IN WS: PER DR. (B)(6), THIS WAS A NON-STERILE ITEM AS THE FILTER NEEDLE THAT IT COMES WITH WAS OPEN WHEN HE OPENED THE BOX. THE BOX WAS CLOSED AND SEALED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PER THE EMAIL FROM THE HCP, "HELLO, NOT SURE WHO I NEED TO LET KNOW ABOUT THIS BUT ABOUT THIS SAMPLE IZERVAY IN WS: PER DR. (B)(6), THIS WAS A NON-STERILE ITEM AS THE FILTER NEEDLE THAT IT COMES WITH WAS OPEN WHEN HE OPENED THE BOX. THE BOX WAS CLOSED AND SEALED." ITEM# 305200. LOT#2172517.

    Description of Event or Problem · 0

    MATERIAL #: 305200. BATCH#: 2172517. IT WAS REPORTED BY CUSTOMER THAT NOT SURE WHO I NEED TO LET KNOW ABOUT THIS BUT ABOUT THIS SAMPLE IZERVAY IN WS: PER DR. YING, THIS WAS A NON-STERILE ITEM AS THE FILTER NEEDLE THAT IT COMES WITH WAS OPEN WHEN HE OPENED THE BOX. THE BOX WAS CLOSED AND SEALED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PER THE EMAIL FROM THE HCP, "HELLO, NOT SURE WHO I NEED TO LET KNOW ABOUT THIS BUT ABOUT THIS SAMPLE IZERVAY IN WS: PER DR. YING, THIS WAS A NON-STERILE ITEM AS THE FILTER NEEDLE THAT IT COMES WITH WAS OPEN WHEN HE OPENED THE BOX. THE BOX WAS CLOSED AND SEALED." ITEM# 305200, LOT#2172517.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488815 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