BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15661221 · Received October 24, 2022

    Report

    Report Number
    1213809-2022-00760
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    October 5, 2022
    Report Date
    November 3, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT THE NEEDLES WERE CLOGGED. NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2007149 AND 2003405. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE QUALITY TEAM¿S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CLOGGED NEEDLE CAN BE TRACED TO THE MANUFACTURING PROCESS. THIS DEFECT COULD OCCUR IF THERE WAS A PROCESS VARIATION AT THE LUBRICATION STATION INDUCING THE SYMPTOM REPORTED. VERIFICATION OF THE LUBRICATION PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2007149; MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026; DEVICE MANUFACTURE DATE: 07-JAN-2021. MEDICAL DEVICE LOT #: 2003405; MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026; DEVICE MANUFACTURE DATE: 03-JAN-2022. 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

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONTINUING TO GET COMPLAINT ABOUT CLOGGED/BLOCKED NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONTINUING TO GET COMPLAINT ABOUT CLOGGED/BLOCKED NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591585 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown