BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 15822703 · Received November 18, 2022

    Report

    Report Number
    3003916417-2022-00261
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 19, 2022
    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: 31-OCT-2022 . SAMPLE AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, FOREIGN MATTER IN THE PACKAGING AND DAMAGED SHIELD WERE OBSERVED. DURING THE SAMPLE EVALUATION, IT WAS NOT POSSIBLE TO IDENTIFY THE FOREIGN MATTER. WHEN OPENING THE PACKAGE, IT ENDED UP COMING OFF, MAKING IT IMPOSSIBLE TO LOCATE IT. AS A SUPERFICIAL PRE-OPENING EVALUATION OF THE PACKAGING, THE DARK COLORED MATERIAL MAY COME FROM WEAR ON THE PACKAGING MACHINE, WHICH CAN DETACH AND ADHERE TO THE OUTSIDE OF THE PROTECTOR OR PACKAGING DUE TO THE STATIC ENERGY CONDITION. POSSIBLE ROOT CAUSE FOR DAMAGED SHIELD IS DUE TO A PLUNGER TANGLE IN THE GRID, WHICH KEEPS THE SET AT AN UNEVEN HEIGHT, CAUSING EXCESS PRESSURE DURING PROTECTOR ASSEMBLY. DURING THE EVALUATION OF THE SAMPLES, IT WAS NOT POSSIBLE TO IDENTIFY THE DAMAGED PACKAGE/HOLE. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 2 BD PRECISIONGLIDE¿ NEEDLES' PACKAGING UNITS HAD HOLES IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "2 UNITS FROM BATCH 2120736 WITH HOLE IN PACKAGING.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PRECISIONGLIDE¿ NEEDLES' PACKAGING UNITS HAD HOLES IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "2 UNITS FROM BATCH 2120736 WITH HOLE IN PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231341 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 2120736

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown