BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRESERVATIVE FLUID

    MDR report key: 2011755 · Received March 4, 2011

    Report

    Report Number
    1062336-2011-00001
    Event Type
    Other
    Date Received
    March 4, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BD DIAGNOSTIC - TRIPATH
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INVOLVING THIS INCIDENT IS CURRENTLY ON-GOING. ACCORDING TO THE INFO RECEIVED FROM THE CUSTOMER, THERE WAS NO DEVICE MALFUNCTION. HOWEVER, THE NURSE WAS EXPOSED TO A PT'S PAP SAMPLE. THE NURSE DID SEEK MEDICAL ATTENTION AT AN EMERGENCY ROOM. THE NURSE HAS NOT REPORTED ADDITIONAL SYMPTOMS. THE DECISION TO FILE WAS BASED ON EXPOSURE OF A MUCOSAL SURFACE TO THE PRESERVATIVE FLUID INCLUDING A PAP SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT THAT SHE SPLASHED SUREPATH PRESERVATIVE FLUID IN HER EYE. THE VIAL OF PRESERVATIVE FLUID DID CONTAIN A PAP SMEAR SAMPLE. SHE SOUGHT MEDICAL ATTENTION AT AN EMERGENCY ROOM WHERE SHE WAS TREATED FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRESERVATIVE FLUID SUREPATH COLLECTION VIAL MKQ BD DIAGNOSTIC - TRIPATH COLLECTION VIAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other