BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 16X1 RB

    MDR report key: 21207052 · Received January 22, 2025

    Report

    Report Number
    1911916-2025-00030
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 30, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP IT WAS REPORTED THERE HAS BEEN A LOT OF CORING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305197 AND LOT NUMBER 4212473. 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. 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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 305197, BATCH#: 4212473. RCC RECEIVED A COMPLAINT VIA EMAIL. SORRY FOR THE EXTENDED TIME FRAME ON A REPLY. I CANNOT NAIL DOWN THE EXACT DATES BECAUSE IT HAPPENS ALL THE TIME NOW. I'VE NOTICED IT MORE OFTEN IN THE PAST 6 MONTHS OR SO. THE ISSUE DIDN'T HURT THE PATIENT THAT WE KNOW OF BECAUSE WE CAUGHT IT. WHAT I AM AFRAID OF IS WE MISS ONE AND IT DOES AFFECT OUR PATIENTS. WE ARE VERY CAREFUL WITH PAYING ATTENTION TO CORING BUT IF IT IS STICKING TO A PORT OR SOMETHING OF THAT NATURE, WE MIGHT MISS IT. THERE ISN'T REALLY A WAY TO PROVIDE A TOTAL NUMBER OF OCCURRENCES BECAUSE WE HAVE SEVERAL IV TECHNICIANS THAT WORK WITH OUR IV COMPOUNDING. TODAY I WILL COUNT HOW MANY OCCURRENCES AND WHAT SPECIFIC VIALS IT HAPPENS TO, SO YOU ARE ABLE TO GET A ROUGH ESTIMATE FOR A TEN-HOUR SHIFT. I WILL ALSO SEE IF I CAN GET OTHER PEOPLE TODAY TO LET ME KNOW WHEN AND WHAT DRUG IT HAPPENS TO. HAS THERE BEEN A CHANGE IN MANUFACTURING IN SOME WAY? OR A DIFFERENT PROCESS IN MANUFACTURING THE NEEDLES? THE CURRENT LOT THAT WE HAVE IS 4212473 WITH AN EXPIRATION OF 09/30/2029 WITH A REFERENCE NUMBER OF 305197. THE TYPE OF NEEDLE WE USE IS BD PRECISION GLIDE NEEDLE 16GX1". I HAVE BEEN WORKING AT THIS FACILITY FOR ALMOST 8 YEARS, AND THIS IS THE FIRST TIME I HAVE HAD SUCH A PROBLEM WITH NEEDLES. WE USE SO MANY OF THESE NEEDLES ON A DAILY BASIS. THANK YOU FOR YOUR HELP AND CONCERN IN THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943599 NEEDLE 16X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4212473 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown