BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ASEPTO¿ SCALP INFUSION SET

    MDR report key: 12407225 · Received September 1, 2021

    Report

    Report Number
    9610048-2021-00122
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 4, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1032509, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE TUBE WAS CUT AND STICKING OUT FROM THE EDGE OF THE PACKAGING. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS AN OPERATOR ERROR THAT OCCURRED DURING THE PACKAGING PROCESS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ASEPTO¿ SCALP INFUSION SET PUNCTURED THROUGH THE PACKAGING UNIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "EXTENSION OF THE MATERIAL SEALED WITH THE PACKAGING, BREAKING IT."

    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 THE BD ASEPTO" SCALP INFUSION SET PUNCTURED THROUGH THE PACKAGING UNIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "EXTENSION OF THE MATERIAL SEALED WITH THE PACKAGING, BREAKING IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301892 BD ASEPTO¿ SCALP INFUSION SET INTRAVENOUS INFUSION SET FPA BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 1032509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown