BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ SYRINGE

    MDR report key: 8240607 · Received January 11, 2019

    Report

    Report Number
    3003916417-2018-00391
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 27, 2018
    Report Date
    January 30, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463006615
    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: IT WAS PERFORMED THE DHR, MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS AND NO DEVIATION WAS FOUND FOR THIS BATCH. NO SAMPLES / PHOTOS WERE SENT BY THE CUSTOMER NOT BEING POSSIBLE PERFORMING AN INVESTIGATION AND DETERMINE THE ROOT CAUSE FOR THE INCIDENT. THE MANUFACTURING PROCESS ARE VALIDATED WITH DEFINED ACCEPTANCE CRITERIA. BD HAS PERFORMED A DEVICE HISTORY RECORD¿S REVIEW (DHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS AND COMPLAINT EVALUATION, THE BATCH INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQLS), AND WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. FROM THESE INFORMATION¿S IT IS NOT POSSIBLE CONFIRM THE COMPLAINT. THE INCIDENT IDENTIFIED BY THIS COMPLAINT WILL BE MONITORED TO TENDENCY ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SOLOMED¿ SYRINGES LEAKED. "THE DRUG USED WAS: DUOFLAM 6,43MG/ML+2,63MG/ML SUS.INJ.-1AMP.X 1ML+SER (SUPERA)." THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    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 #: 7345957; MEDICAL DEVICE EXPIRATION DATE: 2022-11-30; DEVICE MANUFACTURE DATE: 2017-12-12. MEDICAL DEVICE LOT #: 7173924; MEDICAL DEVICE EXPIRATION DATE: 2022-06-30; DEVICE MANUFACTURE DATE: 2017-06-30. (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 THAT BD SOLOMED¿ SYRINGES LEAKED. "THE DRUG USED WAS: DUOFLAM 6,43MG/ML+2,63MG/ML SUS.INJ.-1AMP.X 1ML+SER (SUPERA)." THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34350 BD SOLOMED¿ SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10 07891463006615

    Patients

    Seq Age Sex Outcome Treatment
    1 Other