BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED SYRINGE

    MDR report key: 11312154 · Received February 11, 2021

    Report

    Report Number
    3003916417-2021-00027
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 11, 2021
    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

    H6: INVESTIGATION: IT WAS PERFORMED THE DHR, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WHERE NO RECORDS POTENTIALLY RELATED TO FAILURE WAS FOUND. THE PHOTO AND SAMPLE PROVIDED WAS ANALYZED AND IT WAS POSSIBLE TO OBSERVE BARREL CRACKED. THE POTENTIAL CAUSE FOR THIS IS A SYRINGE ASSEMBLY FAILURE THAT CAUSED THE DAMAGE. CAPA #1035416 WAS INITIATED. THIS IS THE 2ND RELATED COMPLAINT FOR BARREL CRACKED ON THE PROVIDED LOT NUMBER 9190268. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD SOLOMED¿ SYRINGES WERE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "CUSTOMER REPORTS THAT WHEN APPLYING THE PRODUCT, IT WAS NOTICED THAT THE SYRINGE WAS CRACKED, LEADING TO THE WASTE OF THE PRODUCT."

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 BD SOLOMED¿ SYRINGES WERE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER REPORTS THAT WHEN APPLYING THE PRODUCT, IT WAS NOTICED THAT THE SYRINGE WAS CRACKED, LEADING TO THE WASTE OF THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213768 BD SOLOMED SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9190268

    Patients

    Seq Age Sex Outcome Treatment
    1