BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 18X1-1/2IN

    MDR report key: 23835158 · Received December 17, 2025

    Report

    Report Number
    3003916417-2025-00292
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    October 17, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Removal / Correction Number
    MDS-26-06011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SUMMARY OF ASSESSMENT AND ACTIONS TAKEN: A COMPREHENSIVE REVIEW OF THE BATCH HISTORY (DHR) WAS CONDUCTED, INCLUDING MAINTENANCE RECORDS AND QUALITY NOTIFICATIONS. NO DEVIATIONS RELATED TO THE INCIDENT WERE IDENTIFIED. ANALYSIS OF SAMPLES AND EVIDENCE: SAMPLE AND IMAGES OF THE REPORTED INCIDENT WERE RECEIVED AND ANALYZED FOR INITIAL ASSESSMENT. BD CONFIRMS THE INCIDENT. EVALUATION OF PAPER RETENTION SAMPLES (INSPECTIONS EVERY 2 HOURS): INSPECTED BOXES: 01, 92, 179, 274, 378, 482, 593, 701, 810, 919, 1032, 1144, 1255, 1372, 1472, 1588, 1675, 1782, 1898, 2004, AND 2120. EVALUATION OF FINISHED LOT REFERENCE SAMPLES (FINISHED GOODS RETENTION): INSPECTED BOXES: 10, 726, 1085, 1443, 1801, 1259. ROOT CAUSE: DEFECT 1: MIXED PAPER BATCH. DEFECT 2: BARCODE READING SENSOR FAILURE. CONTAINMENT ACTIONS. BARCODE SENSOR VERIFICATION: THE SENSOR READS THE CODE; HOWEVER, THE SYSTEM DOES NOT IDENTIFY THAT THE BARCODE IS INCORRECT. ACTION COMPLETED. SCOPE OF SEEBS: IT WAS FOUND THAT SEEBS 03, 07, 08, 11, 12, AND 15 EXHIBIT THE SAME BEHAVIOR. INVESTIGATION STATUS THE COMPLETE INVESTIGATION IS DOCUMENTED AND ATTACHED IN THE FILE INVESTIGATION OVERVIEW.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. FIELD ACTION NOTIFICATION: MDS-26-06011.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE PRECISIONGLIDE 18X1-1/2IN LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT I HEREBY INFORM YOU OF THE RECEIPT OF AN INTERNAL TECHNICAL COMPLAINT REGARDING THE PACKAGING OF (B)(6) UNITS OF 40X12 NEEDLES. THE PRODUCT IS A 40X12 NEEDLE, BUT THE PACKAGING SHOWS A BARCODE AND OTHER INFORMATION REFERRING TO SIZE 80X30, AS SHOWN IN THE ATTACHED PHOTO. BOX BATCH: 5212927. ADDITIONAL INFORMATION RECEIVED ON 27 OCT 2025. WHEN WAS THE PROBLEM/DEFECT IDENTIFIED: BEFORE, DURING, OR AFTER USE? BEFORE. WAS THE INCIDENT REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? (B)(4). COULD YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? (B)(6) 2025. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? YES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    FIELD ACTION NOTIFICATION: MDS-26-06011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336493 BD NEEDLE PRECISIONGLIDE 18X1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 5212927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown