BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML W/SND CURITIBA

    MDR report key: 8505444 · Received April 11, 2019

    Report

    Report Number
    3003916417-2019-00197
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 27, 2019
    Report Date
    May 2, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR, QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS WERE PERFORMED AND NO OCCURRENCES POTENTIALLY RELATED TO THE DEFECT WAS OBSERVED. THE IMAGE AND SAMPLE SENT BY THE CUSTOMER WAS VERIFIED AND IT WAS POSSIBLE OBSERVE BARREL CRACKED. THE POTENTIAL CAUSE FOR THE OCCURRENCE IS A FAILURE AT SYRINGE ASSEMBLY STATION, WHICH CAUSED THE BARREL CRACKED AND THE LEAKAGE DURING THE SYRINGE USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 3ML W/SND CURITIBA BARREL HAD CRACKS IN IT THAT ALLOWED LIQUID TO LEAK INTO THE SYRINGE DURING USE, BUT AFTER REOCCURRENCE OF THE DEFECT, A "FISSURE" WAS NOTICED IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WE ARE NOTICING SEVERAL 3ML BD SYRINGES, LOT 7132878 (VALIDITY 06/22) WITH LEAKAGE INTO THE SYRINGE BODY. APPARENTLY IT HAS HOLES OR CRACKS IN THE HEIGHT OF 2.5ML AND THE LIQUID BEING INJECTED BEGINS TO LEAK. I ROUTE TWO UNITS THAT ARE WITH VISIBLE CRACKS." INFORMATION RECEIVED BY EMAIL ON 4/4/2019: THE INCIDENT WAS INITIALLY NOTICED DURING THE USE, BUT BECAUSE OF THE RECURRENCE OF THE DEFECT, THEY SAW THAT THE SYRINGE WAS WITH A FISSURE YET IN THE PACKAGE. THE CUSTOMER CAN NOT INFORM THE DRUG USED BECAUSE THE COWORKERS WOULD NOT REMIND IT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (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 THE SYRINGE 3ML W/SND CURITIBA BARREL HAD CRACKS IN IT THAT ALLOWED LIQUID TO LEAK INTO THE SYRINGE DURING USE, BUT AFTER REOCCURRENCE OF THE DEFECT, A "FISSURE" WAS NOTICED IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WE ARE NOTICING SEVERAL 3ML BD SYRINGES, LOT 7132878 (VALIDITY 06/22) WITH LEAKAGE INTO THE SYRINGE BODY. APPARENTLY IT HAS HOLES OR CRACKS IN THE HEIGHT OF 2.5ML AND THE LIQUID BEING INJECTED BEGINS TO LEAK. I ROUTE TWO UNITS THAT ARE WITH VISIBLE CRACKS." INFORMATION RECEIVED BY EMAIL ON 4/4/2019: THE INCIDENT WAS INITIALLY NOTICED DURING THE USE, BUT BECAUSE OF THE RECURRENCE OF THE DEFECT, THEY SAW THAT THE SYRINGE WAS WITH A FISSURE YET IN THE PACKAGE. THE CUSTOMER CAN NOT INFORM THE DRUG USED BECAUSE THE COWORKERS WOULD NOT REMIND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298410 SYRINGE 3ML W/SND CURITIBA SYRINGE WITH NEEDLE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 7132878

    Patients

    Seq Age Sex Outcome Treatment
    1 Other