BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18GA 1IN BLUNT FILL SLA

    MDR report key: 19562811 · Received June 18, 2024

    Report

    Report Number
    3003916417-2024-00158
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    UDI-DI
    30000078910349
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DEFECTS OR ISSUES OBSERVED. PHYSICAL SAMPLE OR ADDITIONAL PHOTOS OF THE INCIDENT IS REQUIRED TO FURTHER ANALYZE AND DETERMINE A ROOT CAUSE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 18GA 1IN BLUNT FILL SL PACKAGE HAD POOR PERFORATION / SLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: MATERIAL WITH QUALITY DEFECTS - AF 141194/3 - IT WAS NOTED THAT IN BATCH 0182885 THE PACKAGING DID NOT COME WITH A SERRATED PART PROBE 25MMX1. 2DMM FOR DRUG ASPIRATION - BLUNT TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936629 BD NEEDLE 18GA 1IN BLUNT FILL SLA NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 0182885 30000078910349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown