BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALPAK 5ML AZUL HOSPITAL

    MDR report key: 10892709 · Received November 24, 2020

    Report

    Report Number
    3003916417-2020-00343
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    September 11, 2020
    Report Date
    January 22, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-01-05 H6: INVESTIGATION SUMMARY THE QUALITY DEP PERFORMED THE INVESTIGATION OF THE CUSTOMER COMPLAINT, WITH INFORMED THE DEFECT FOREIGN MATTER. THE IMAGE PROVIDED SHOW PARTICLE INSIDE THE SYRINGE BARREL. ACCORDING THE DHR EVALUATION IT WAS NOT OBSERVED ANY RECORD TO THIS ISSUE. AFTER EVALUATING THE IMAGES, IT SHOW THE SAME CHARACTERISTIC RESULTANT FROM THE MIGRATION OF THE LUBRICANT OIL PRESENT AT CHEMICAL COMPOSITION OF THE RAW MATERIAL USED TO SYRINGE PRODUCTION, INHERENT TO THE PRODUCT. THIS LUBRICANT WAS CALLED OLEAMIDE OIL WITH RESPONSIBLE TO THE MOVEMENT FROM THE PLUNGER AND BARREL OF THE SYRINGE, WITHOUT THIS COMPONENT THE MOVEMENT IS IMPOSSIBLE. THIS ELEMENT WAS SPECIFIC TO THE HEALTH CARE APPLICATIONS, AS ORAL SYRINGE, ALSO WAS CLASSIFIED AT CATEGORY 1 ¿ MEDICAL DEVICES. NO IMPACT TO THE HEALTH. THIS PRODUCT HAS BEEN EVALUATED IN ACCORDANCE WITH ISO 10993 "BIOLOGICAL EVALUATION OF MEDICAL DEVICES", AND COMPLIES WITH ALL RELEVANT SECTIONS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 300 ORALPAK 5ML AZUL HOSPITAL EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE'VE RECEIVED ABOUT (B)(4) UNITS THAT REMAIN PLASTIC RESIDUES INSIDE THE SYRINGES, THAT ARE RELEASED FROM THE PLUNGER.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). 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 300 ORALPAK 5ML AZUL HOSPITAL EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE'VE RECEIVED ABOUT (B)(4) UNITS THAT REMAIN PLASTIC RESIDUES INSIDE THE SYRINGES, THAT ARE RELEASED FROM THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359696 ORALPAK 5ML AZUL HOSPITAL SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8327925

    Patients

    Seq Age Sex Outcome Treatment
    1