BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ SYRINGE

    MDR report key: 7436863 · Received April 17, 2018

    Report

    Report Number
    3003916417-2018-00060
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 30, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. ANALYSIS OF BATCH HISTORY: LOT 7072702 WAS PRODUCED FROM 08 / APR / 2017 TO 13 / APR / 2017. LOT 7072706 WAS PRODUCED FROM 25 / APR / 2017 TO 27 / APR / 2017. THE INSPECTIONS CARRIED OUT ON THE PRODUCT WERE VERIFIED AND NO RECORDS OF THE CLAIMED DEFECT IN THE BATCH HISTORY WERE EVIDENCED. THE INSPECTIONS PERFORMED ON THE MOIJ 52 INJECTION MOLDING MACHINE AND BH-03 MOLD WERE CHECKED AND THERE IS EVIDENCE OF CORRECTIVE MAINTENANCE. HOWEVER, IT IS NOT POSSIBLE TO CONFIRM THAT THE CORRECTION IS RELATED TO THE DEFECT WITHOUT SAMPLE ANALYSIS. BEFORE THE BATCH IS RELEASED TO THE CONSUMER, THE PRODUCT STILL GOES THROUGH THE PROCESS OF EVALUATION OF THE FINAL INSPECTION LABORATORY, WHERE MORE VALIDATED VISUAL TESTS ARE PERFORMED, CERTIFYING THE CONFORMITY OF THE PRODUCT. AFTER REVIEWING THIS DOCUMENT, IT CAN BE VERIFIED THAT ALL THE TESTS PERFORMED WERE WITHIN THE SPECIFICATIONS OF THE PRODUCT. NO RECORD WAS FOUND THAT COULD LEAD TO THIS DEFECT. CAPA IS NOT REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING BD SOLOMED¿ SYRINGE(S) MULTIPLE DEFECTS OCCUR SUCH AS LEAKING, BROKEN SYRINGE AND ¿ASPIRATING MORE AIR THEN MEDICINE¿. THERE WAS NO REPORT OF TREATMENT CHANGES EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281085 BD SOLOMED¿ SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other