BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 16403449 · Received February 20, 2023

    Report

    Report Number
    3003916417-2023-00035
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 20, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 01-MAR-2023. INVESTIGATION SUMMARY: FIFTEEN SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION. NO OTHER DEFECTS OR ISSUES FOUND, UNABLE TO CONFIRM DAMAGED PACKAGE OR SHIELD DAMAGED. NO INTERNAL CONTAMINATION WAS VERIFIED DUE TO A COMPROMISE OF THE PACKAGING AND NO DAMAGES OR DEFORMATIONS WERE VERIFIED IN THE SHIELD. 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2180498. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. DEVICE MANUFACTURE DATE: 29-JUN-2022. MEDICAL DEVICE LOT #: 2120736. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. DEVICE MANUFACTURE DATE: 30-APR-2022. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 BD PRECISIONGLIDE¿ NEEDLES FROM LOT 2180498, AND 1 NEEDLE FROM LOT 2120736 HAD HOLES IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "9 OF BATCH 2180498 WITH HOLE IN PACKAGING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 BD PRECISIONGLIDE¿ NEEDLES FROM LOT 2180498, AND 1 NEEDLE FROM LOT 2120736 HAD HOLES IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "9 OF BATCH 2180498 WITH HOLE IN PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374276 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown