BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL® INFANT CATH KIT

    MDR report key: 8108877 · Received November 27, 2018

    Report

    Report Number
    1018233-2018-05642
    Event Type
    Injury
    Date Received
    November 27, 2018
    Report Date
    January 18, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FFH
    UDI-DI
    00801741045844
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿PRODUCT DOES NOT CONTAIN IODINE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO INFANT CATHETER KITS WERE SENT, RECEIVED AND USED ON ONE INFANT WITHOUT THE POVIDONE-IODINE INCLUDED. REPORTEDLY, AS A RESULT, THE INFANT CONTRACTED A URINARY TRACT INFECTION. THE UTI WAS TREATED WITH ANTIBIOTICS. IT WAS NOTED THAT THE YELLOW LABEL INDICATING THE ABSENCE OF THE POVIDONE-IODINE WAS ADHERED TO THE PACKAGING. HOWEVER, THE NURSE DID NOT NOTICE THE LABEL UPON FIRST LOOKING AT THE PACKAGE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO INFANT CATHETER KITS WERE SENT, RECEIVED AND USED ON ONE INFANT WITHOUT THE POVIDONE-IODINE INCLUDED. REPORTEDLY, AS A RESULT, THE INFANT CONTRACTED A URINARY TRACT INFECTION. THE UTI WAS TREATED WITH ANTIBIOTICS. IT WAS NOTED THAT THE YELLOW LABEL INDICATING THE ABSENCE OF THE POVIDONE-IODINE WAS ADHERED TO THE PACKAGING. HOWEVER, THE NURSE DID NOT NOTICE THE LABEL UPON FIRST LOOKING AT THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948524 DAVOL® INFANT CATH KIT INFANT CATHETER KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 NGCS1862 00801741045844

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention