BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 21X1-1/4IN

    MDR report key: 25151545 · Received May 12, 2026

    Report

    Report Number
    3003916417-2026-00070
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INV B2B-NEEDLE PRECISIONGLIDE 21X1-1/4IN HAD EXCESSIVE EPOXY. DURING THE RECENT INSPECTION, EXCESS GLUE ON THE NEEDLES WAS AGAIN DETECTED DURING THE AQL 1.0 / LEVEL S-2 MATERIAL REVIEW FOR THE FOLLOWING LOTS: PRODUCT: 300078 NEEDLE PRECISIONGLIDE 21X1-1/4IN BATCHES 6023986; 6023987 QUANTITY: 7 PIECES (6023986 - 3 PIECES; 6023987 - 4 PIECES) ADDITIONAL INFORMATION RECEIVED ON 29-APR-2026. EMAIL FOLLOW UP: WOULD YOU BE SO KIND AS TO CONFIRM THE SAMPLE SIZE FOR EACH BATCH REPORTED, PLEASE? THE SAMPLE SIZE IS DETERMINED ACCORDING TO ANSI TABLES, BASED ON THE NUMBER OF PARTS RECEIVED. IN THIS CASE, AS MENTIONED IN THE COMPLAINT, THE MATERIAL INSPECTION WAS CONDUCTED AT LEVEL S-2. WITH AN AQL OF 1.0, THE ACCEPTANCE CRITERION IS SET AT 0 DEFECTIVE PARTS, AND REJECTION OCCURS IF THERE IS 1 OR MORE DEFECTIVE PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526525 BD NEEDLE PRECISIONGLIDE 21X1-1/4IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 6023986

    Patients

    Seq Age Sex Outcome Treatment
    1