BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED SYRINGE

    MDR report key: 10687269 · Received October 15, 2020

    Report

    Report Number
    3003916417-2020-00308
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 21, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 9190255, D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2024, H.4. DEVICE MANUFACTURE DATE: 7/22/2019. H.6. INVESTIGATION: IT WAS PERFORMED THE DHR, MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS AND NO DEVIATION WERE FOUND FOR THIS BATCH. NO SAMPLES / PHOTOS WERE SENT BY THE CUSTOMER MAKING IT NOT POSSIBLE TO PERFORM AN INVESTIGATION AND DETERMINE THE ROOT CAUSE FOR THE INCIDENT. THE MANUFACTURING PROCESS ARE VALIDATED WITH DEFINED ACCEPTANCE CRITERIA. FROM THIS INFORMATION IT IS NOT POSSIBLE CONFIRM THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SOLOMED¿ SYRINGE NEEDLE WAS FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WE RECEIVED A MARKET COMPLAINT IN WHICH THE CUSTOMER REPORTS THAT THE NEEDLE IS BROKEN."

    Additional Manufacturer Narrative · 1

    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 #: 9190255. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-22. MEDICAL DEVICE LOT #: 9190258. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-22. MEDICAL DEVICE LOT #: 9190282. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-22. MEDICAL DEVICE LOT #: 9226943. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-08-27. 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 THE BD SOLOMED¿ SYRINGE NEEDLE WAS FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WE RECEIVED A MARKET COMPLAINT IN WHICH THE CUSTOMER REPORTS THAT THE NEEDLE IS BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152743 BD SOLOMED SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9190255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other