BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1 RB

    MDR report key: 20129287 · Received September 3, 2024

    Report

    Report Number
    1911916-2024-00642
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. IT WAS REPORTED THE NEEDLE WAS IN A SEALED PACKAGE, HAD NO SHIELD AND APPEARS TO HAVE RUST PARTICULATES ON IT. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. TWO PHOTOS SHOW PACKAGING SHELF BOXES. THE THIRD PHOTO SHOWS A NEEDLE ASSEMBLED TO A SYRINGE WITH THE PLASTIC SHIELD REMOVED AND AN OPENED PACKAGING BLISTER. THE NEEDLE HAS A DARK COLORED PARTICLE ADHERED TO IT THAT APPEARS TO BE A PARTICULATE OF DUST. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305195, LOT 4060183. 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 IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL # 305195 . BATCH # 4060183. IT WAS REPORTED BY CUSTOMER THAT NEEDLE WAS IN A SEALED PACKAGE, NO LID AND APPEARS TO HAVE RUST PARTICULATES ON IT. VERBATIM: I WANTED TO PASS ALONG A NEEDLE WE FOUND IN OUR IV ROOM LAST NIGHT. THIS NEEDLE WAS IN A SEALED PACKAGE, NO LID AND APPEARS TO HAVE RUST PARTICULATES ON IT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 305195; BATCH # 4060183. IT WAS REPORTED BY CUSTOMER THAT NEEDLE WAS IN A SEALED PACKAGE, NO LID AND APPEARS TO HAVE RUST PARTICULATES ON IT. VERBATIM: I WANTED TO PASS ALONG A NEEDLE WE FOUND IN OUR IV ROOM LAST NIGHT. THIS NEEDLE WAS IN A SEALED PACKAGE, NO LID AND APPEARS TO HAVE RUST PARTICULATES ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186889 NEEDLE 18X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4060183 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown