BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18GA 1IN BLUNT FILL SLA

    MDR report key: 9935979 · Received April 8, 2020

    Report

    Report Number
    3003916417-2020-00114
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 17, 2020
    Report Date
    April 16, 2020
    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

    H.6. INVESTIGATION: BATCH HISTORY ANALYSIS (DHR), MAINTENANCE RECORDS AND QUALITY NOTIFICATIONS WERE VERIFIED AND A MAINTENANCE RECORD WAS FOUND ON THE NEEDLE WRAPPING MACHINE RELATED TO THE DAMAGED PROTECTIVE DEFECT CLAIMED BY THE CUSTOMER FOR THIS BATCH. WE RECEIVED THE SAMPLE SENT FOR EVALUATION, SO IT WAS POSSIBLE TO CONDUCT AN INVESTIGATION, CONFIRM A CLAIM FOR THE BROKEN PROTECTIVE DEFECT AND DETERMINE THE ROOT CAUSE. THE INCIDENT OCCURRED DUE TO A PROTECTOR ENTANGLEMENT IN THE ASSEMBLY LINE BECOMING MISALIGNED CAUSING THE INCIDENT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE NEEDLE TIP WAS DISCOVERED TO BE DEFECTIVE WITH A BD NEEDLE (B)(4) GA (B)(4) IN BLUNT FILL SLA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: NEEDLE TIP IS IRREGULAR.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE NEEDLE TIP WAS DISCOVERED TO BE DEFECTIVE WITH A BD NEEDLE 18GA 1IN BLUNT FILL SLA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: NEEDLE TIP IS IRREGULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400265 BD NEEDLE 18GA 1IN BLUNT FILL SLA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9197336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other