BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 21X1-1/4IN

    MDR report key: 11033425 · Received December 17, 2020

    Report

    Report Number
    3003916417-2020-00363
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    August 20, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT WAS PERFORMED THE DHR, THE QUALITY NOTIFICATIONS (200898873), AND RECORDS OF MAINTENANCE ((B)(4)) WHERE IT HAS BEEN OPENED FOR POTENTIALLY FAILURE RELATED RECORDS. THE IMAGES WERE EVALUATED, AND IT WAS POSSIBLE TO OBSERVE FAILURE IN THE BATCH PRINTING. THE POSSIBLE CAUSES FOR THE OCCURRENCE: FAULT IN CARTRIDGE PRINT LINE. INSUFFICIENT INK IN THE CARTRIDGE. MACHINE CONTACT FAILURES WITH THE CARTRIDGES, CAUSING PRINTING FAILURES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 681 NEEDLE PRECISIONGLIDE 21X1-1/4IN. EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE REVIEW, WE HAD (B)(4) UNITS DISAPPROVED FROM BATCH 0182648.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 681 NEEDLE PRECISIONGLIDE 21X1-1/4IN EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE REVIEW, WE HAD 681 UNITS DISAPPROVED FROM BATCH 0182648.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498832 NEEDLE PRECISIONGLIDE 21X1-1/4IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 0182648

    Patients

    Seq Age Sex Outcome Treatment
    1