BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE SOLOMED 3ML LL 22X1-1/4

    MDR report key: 9285466 · Received November 6, 2019

    Report

    Report Number
    3003916417-2019-00561
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 18, 2019
    Report Date
    November 25, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WERE REVIEWED WHERE NO RECORDS POTENTIALLY RELATED TO THE FAILURE WERE FOUND. THE SAMPLE PROVIDED WAS ANALYZED AND IT WAS POSSIBLE TO OBSERVE BARREL CRACKED. THE POSSIBLE CAUSE FOR THIS IS A FAILURE AT SYRINGE ASSEMBLY STATION WITH CAUSED THE DAMAGE. TO DEFINE AND MANAGE ACTIONS TO CORRECT THE INCIDENT, THE CAPA 1035416 WAS OPENED. SOME ACTIONS PERFORMED: SYNCHRONIZE ADJUSTMENT ON THE TRANSFER DISK; CREATE A POKA YOKE TO ENSURE STAYING IN THE CORRECT POSITION. DESIGN NEW TOP DISC GUIDE AFTER LEAK TEST. MAKE TOP DISC GUIDE AFTER LEAK TEST. DESIGN NEW BOTTOM DISC WITH ACCEPTED ANGLE FOR CYLINDER ENTRY. MAKE LOWER DISC WITH ACCEPTED ANGLE FOR CYLINDER ENTRY. THE INCIDENT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACKED BARREL OCCURRED DURING USE WITH A SYRINGE SOLOMED 3ML LL 22X1-1/4. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE LOT NUMBER IS 9190253. THE INCIDENT WAS NOTICED BEFORE THE USE. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL, BUT THE DRUG WAS LOST. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. AFTER FILLING THE SYRINGE, IT WAS NOTICED LEAKAGE IN THE SYRINGE BODY. THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPIC TO THE SKIN OR MUCOUS. THE DRUG USED WS HEMAX ERITRON (4000 UI). THERE IS 4 SAMPLES UNIT AVAILABLE."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACKED BARREL OCCURRED DURING USE WITH A SYRINGE SOLOMED 3ML LL 22X1-1/4. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE LOT NUMBER IS 9190253. THE INCIDENT WAS NOTICED BEFORE THE USE. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL, BUT THE DRUG WAS LOST. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. AFTER FILLING THE SYRINGE, IT WAS NOTICED LEAKAGE IN THE SYRINGE BODY. THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPIC TO THE SKIN OR MUCOUS. THE DRUG USED WS HEMAX ERITRON (4000 UI). THERE IS 4 SAMPLES UNIT AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077765 SYRINGE SOLOMED 3ML LL 22X1-1/4 SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9190253

    Patients

    Seq Age Sex Outcome Treatment
    1 Other