BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALPAK 10ML BLUE HOSPITAL

    MDR report key: 11131400 · Received January 7, 2021

    Report

    Report Number
    3003916417-2021-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 9, 2020
    Report Date
    February 17, 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

    H6: INVESTIGATION SUMMARY: 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 IN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ORALPAK 10ML BLUE HOSPITAL WAS DAMAGED AND HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WHEN YOU REMOVE THE PLUNGER TO PLACE THE MEDICINE, THE PLASTIC SPREADS INTO VERY SMALL PIECES INSIDE THE SYRINGE. THERE IS A RISK OF FRAGMENTS REMAINING AND BEING CARRIED ALONG WITH THE MEDICATION AND THE CHILD INGESTING IT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A ORALPAK 10ML BLUE HOSPITAL WAS DAMAGED AND HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WHEN YOU REMOVE THE PLUNGER TO PLACE THE MEDICINE, THE PLASTIC SPREADS INTO VERY SMALL PIECES INSIDE THE SYRINGE. THERE IS A RISK OF FRAGMENTS REMAINING AND BEING CARRIED ALONG WITH THE MEDICATION AND THE CHILD INGESTING IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30849 ORALPAK 10ML BLUE HOSPITAL PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8205724

    Patients

    Seq Age Sex Outcome Treatment
    1