BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 19907702 · Received August 5, 2024

    Report

    Report Number
    1911916-2024-00568
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    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

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE NEEDLE LOOKED VISIBLY DIRTY. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION, AND THEN WITH 30X MAGNIFICATION. NO DEFECTS, IMPERFECTIONS OR FOREIGN MATTER OF ANY KIND WAS OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4093950. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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 ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, A NEW NEEDLE WAS USED MATERIAL: 305196 BATCH#: 4093950 IT WAS REPORTED BY THE CUSTOMER THAT A TEAM MEMBER WENT TO USE A STERILE 18G NEEDLE, UPON OPENING THE WRAPPER AND UNCAPPING THE NEEDLE, THE NEEDLE LOOKED VISIBLY DIRTY. IT WAS NOT USED IN ANY WAY BESIDES OPENING THE WRAPPER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ON 7/31/24, A TEAM MEMBER WENT TO USE A STERILE 18G NEEDLE, UPON OPENING THE WRAPPER AND UNCAPPING THE NEEDLE, THE NEEDLE LOOKED VISIBLY DIRTY. IT WAS NOT USED IN ANY WAY BESIDES OPENING THE WRAPPER. LOT AND EXP DATE ARE ATTACHED IN THE PICTURES. LET US KNOW IF YOU WOULD LIKE THIS NEEDLE SENT OUT FOR FURTHER INVESTIGATION OR IF IT SHOULD BE PROPERLY DISPOSED OF. PRODUCT NUMBER - 305196. LOT NUMBER - 4093950.

    Description of Event or Problem · 0

    MATERIAL: 305196. BATCH#: 4093950. IT WAS REPORTED BY THE CUSTOMER THAT A TEAM MEMBER WENT TO USE A STERILE 18G NEEDLE, UPON OPENING THE WRAPPER AND UNCAPPING THE NEEDLE, THE NEEDLE LOOKED VISIBLY DIRTY. IT WAS NOT USED IN ANY WAY BESIDES OPENING THE WRAPPER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON (B)(6) 2024, A TEAM MEMBER WENT TO USE A STERILE 18G NEEDLE, UPON OPENING THE WRAPPER AND UNCAPPING THE NEEDLE, THE NEEDLE LOOKED VISIBLY DIRTY. IT WAS NOT USED IN ANY WAY BESIDES OPENING THE WRAPPER. LOT AND EXP DATE ARE ATTACHED IN THE PICTURES. LET US KNOW IF YOU WOULD LIKE THIS NEEDLE SENT OUT FOR FURTHER INVESTIGATION OR IF IT SHOULD BE PROPERLY DISPOSED OF. PRODUCT NUMBER - 305196. LOT NUMBER - 4093950.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844911 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4093950 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown