BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH IV CATHETER

    MDR report key: 10269548 · Received July 14, 2020

    Report

    Report Number
    9610048-2020-00102
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    April 27, 2020
    Report Date
    July 14, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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, 7241831, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE TOP OF THE PACKAGE WAS OPEN. IT SHOULD ALSO BE NOTED THAT IN THE PROVIDED PHOTO THERE WAS A SEALING MARK ON THE FILM, WHICH SHOWED THAT SEALING OCCURRED NORMALLY DURING THE SEALING PROCESS. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THERE WAS AN ISSUE WITH THE SUPPLIER WHO PROVIDED THE PAPER. A NOTIFICATION HAS BEEN ISSUED TO THIS SUPPLIER TO INFORM THEM OF THIS ISSUE AND A NEW SUPPLIER HAS BEEN CHOSEN MOVING FORWARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD ANGIOCATH¿ IV CATHETERS' PACKAGING UNITS WERE FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE NURSE FOUND A PACKING PROBLEM (BROKEN PACKAGE) WHEN PREPARING FOR USE IN THE MORNING AND RETURNED IT TO THE SUPPLY ROOM".

    Additional Manufacturer Narrative · 1

    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 4 BD ANGIOCATH IV CATHETERS' PACKAGING UNITS WERE FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE NURSE FOUND A PACKING PROBLEM (BROKEN PACKAGE) WHEN PREPARING FOR USE IN THE MORNING AND RETURNED IT TO THE SUPPLY ROOM"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733090 BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381112 7241831 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other