BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17798528 · Received September 22, 2023

    Report

    Report Number
    1213809-2023-01057
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 7, 2023
    Report Date
    January 20, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THE NEEDLE WAS BENT AND RESISTANCE WAS FELT. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD WAS REVIEWED FOR PROVIDED MATERIAL NUMBER 305916, LOT 3093522. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 3093522 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION FOR THESE TYPES OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THESE BATCHES. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO ENSURE THE NEEDLE LUBRICATION IS APPLIED APPROPRIATELY. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED: MAT# 305916, LOT# 3093522. IT WAS REPORTED BY THE CUSTOMER THAT HERE WAS A BENT NEEDLE AND RESISTANCE WAS FELT WITH NEEDLE BEING CLOGGED/BLOCKED VERBATIM : COMPLAINT RECEIVED VIA PHONE. PIR ATTACHED PRODUCT COMPLAINT: (B)(6), NOT SURE WHEN THE ISSUE OCCURRED BUT THEY RECEIVED THE COMPLAINT 06-SEP-2023. ALSO MENTIONED THEY HAD REPORTS OF ISSUES WHERE RESISTANCE WAS FELT WITH NEEDLE BEING CLOGGED/BLOCKED. 305916, LOT 3093522. THERE IS NO PATIENT HARM OR ADVERSE EVENT THAT THEY ARE AWARE OF. CUSTOMER WOULD LIKE ALL COMMUNICATIONS TO BE SENT TO BOTH EMAILS BELOW. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ADVISED THAT THERE WAS A BENT NEEDLE, NOT SURE WHEN THE ISSUE OCCURRED BUT THEY RECEIVED THE COMPLAINT (B)(6) 2023. ALSO MENTIONED THEY HAD REPORTS OF ISSUES WHERE RESISTANCE WAS FELT WITH NEEDLE BEING CLOGGED/BLOCKED. 305916. LOT 3093522 THERE IS NO PATIENT HARM OR ADVERSE EVENT THAT THEY ARE AWARE OF. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117340 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 3093522 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown