BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ HYPODERMIC NEEDLE

    MDR report key: 8106171 · Received November 27, 2018

    Report

    Report Number
    3003916417-2018-00326
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 28, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE PULLED OUT OF HUB ON THE PROVIDED LOT NUMBER. DHR REVIEW: 8030748 - IT WAS PERFORMED THE DHR REVIEW AND THE MANUFACTURING DATE WAS FEBRUARY 17TH - 22ND, 2018. THE PROCESS INSPECTIONS WERE PERFORMED AND NO RECORDS OF THIS INCIDENT WERE FOUND. THE CURRENT CONTROLS AT MANUFACTURING PROCESS TO DETECT THE INCIDENT, ARE PERFORMED BY CANNULA MISSING INSPECTION EACH 02 HOURS AT 40 PARTS AT PACKAGING PROCESS. 8030603 - IT WAS PERFORMED THE DHR REVIEW AND THE MANUFACTURING DATE WAS FEBRUARY 16TH ¿ 19TH, 2018. THE PROCESS INSPECTIONS WERE PERFORMED AND NO RECORDS OF THIS INCIDENT WERE FOUND. THE CURRENT CONTROLS AT MANUFACTURING PROCESS TO DETECT THE INCIDENT, ARE PERFORMED BY CANNULA MISSING INSPECTION EACH 02 HOURS AT 50 PARTS AT ASSEMBLY PROCESS. QN REVIEW: NO QUALITY NOTIFICATIONS POTENTIALLY RELATED TO THE FAILURE MODE WERE OBSERVED IN THE BATCHES. MAINTENANCE REVIEW: NO MAINTENANCE RECORD POTENTIALLY RELATED TO THE FAILURE MODE WERE OBSERVED IN THE BATCHES. THE SAMPLE OF PRODUCT WAS SENT BY THE CUSTOMER, WITH THAT WAS POSSIBLE PERFORMING AN INVESTIGATION, CONFIRMING THE FAILURE AND DETERMINE THE PROBABLE ROOT CAUSE. THE DEFECT NEEDLE PULLED OUT OF HUB, ACCORDING SAMPLE SENT BY THE CUSTOMER, OCCURRED DUE TO ONE MOLDING PROCESS. THE DEFECT IDENTIFIED BY THIS COMPLAINT WILL BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PRECISIONGLIDE¿ HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH NEEDLE PULLED OUT OF HUB.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD PRECISIONGLIDE¿ HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH NEEDLE PULLED OUT OF HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948664 BD PRECISIONGLIDE¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 8030748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other