BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 9437785 · Received December 9, 2019

    Report

    Report Number
    1213809-2019-01237
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS COMPLAINT WAS RE-EVALUATED AND WAS DETERMINED TO BE NOT REPORTABLE. THE FOREIGN MATTER ON RETURNED DEVICE WAS NOT IN THE FLUID PATHWAY. REPORTABILITY DETERMINATION RATIONALE: THIS IS NOT MDR REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. FOREIGN MATTER NOT WITHIN THE FLUID PATHWAY MAY CAUSE A CUSTOMER INCONVENIENCE BUT WILL NOT LEAD TO ANY DEGREE OF HARM/SERIOUS INJURY.

    Description of Event or Problem · 0

    MATERIAL NO: 305901 BATCH NO: 9170941. IT WAS REPORTED THAT BEFORE USE OF THE BD SAFETYGLIDE¿ NEEDLE FOREIGN MATTER CONTAMINATION WAS FOUND IN PRODUCT PACKAGING AND SEAL/SEAM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, WE DISCOVERED A CONTAMINATION ISSUE WITH 5 EACH R0459 / 305901 NEEDLE: 25 GA X .625 SAFETY GLIDE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 305901 BATCH NO: 9170941. IT WAS REPORTED THAT BEFORE USE OF THE BD SAFETYGLIDE¿ NEEDLE FOREIGN MATTER CONTAMINATION WAS FOUND IN PRODUCT PACKAGING AND SEAL/SEAM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, WE DISCOVERED A CONTAMINATION ISSUE WITH 5 EACH R0459 / 305901 NEEDLE: 25 GA X .625 SAFETY GLIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237194 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305901 9170941 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other