BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALPAK 3ML BLUE HOSPITAL

    MDR report key: 10446382 · Received August 24, 2020

    Report

    Report Number
    3003916417-2020-00248
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 2, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: NO D.10. RETURNED TO MANUFACTURER ON: N/A H.6. INVESTIGATION: SAMPLES/ PHOTOS ANALYSIS: AN IMAGE WAS RECEIVED, AND IT IS POSSIBLE OBSERVE PARTICLE INSIDE THE SYRINGE BODY. THE RETAIN SAMPLES WERE EVALUATED AND IT WAS POSSIBLE OBSERVE THE SIMILAR CHARACTERISTIC OBSERVED BY THE CUSTOMER, TO CORRELATE THE OCCURRENCE WITH INHERENT PRODUCT CHARACTERISTICS BEING A RESIDUE OF LUBRICATING AGENT - CRODAMIDE. ACCORDING THE DHR EVALUATION IT WAS NOT OBSERVED ANY RECORD TO THIS ISSUE. AFTER EVALUATING THE IMAGES, IT SHOWS 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ORALPAK 3ML BLUE HOSPITAL HAD FOREIGN MATTER IN THE BARREL ON 73 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE FM FOUND IN BARREL. CUSTOMER REQUEST FM ANAYSIS/ REQUEST CONFIRM WHITE FM IS CRODAMIDE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ORALPAK 3ML BLUE HOSPITAL HAD FOREIGN MATTER IN THE BARREL ON 73 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE FM FOUND IN BARREL. CUSTOMER REQUEST FM ANALYSIS/ REQUEST CONFIRM WHITE FM IS CRODAMIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911045 ORALPAK 3ML BLUE HOSPITAL SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8327682

    Patients

    Seq Age Sex Outcome Treatment
    1 Other