BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREPATH COLLECTION KIT

    MDR report key: 1040932 · Received May 9, 2008

    Report

    Report Number
    1216677-2008-00013
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    March 10, 2008
    Report Date
    May 8, 2008
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 57149. SUBJECT LOT 57148 WAS PRODUCED IN AUGUST 2007. SUBJECT LOT 57149 WAS PRODUCED IN OCTOBER 2007. COOPERSURGICAL PRODUCES THIS PRODUCT. COOPERSURGICAL WAS INFORMED OF THIS EVENT VIA LETTER DATED MARCH 21, 2008 AND WE ARE REPORTING ALSO AT THIS TIME AS WE ARE IN RECEIPT OF MDR# 1062336-2008-00004. REPORTER HAD INDICATED THE CLINICIAN WAS NOT USING THE SPATULA IN ONE OF THE THREE RECOMMENDED TECHNIQUES. THE CLINICIAN WAS NOT WEARING ANY PROTECTIVE EYE WEAR AS RECOMMENDED. THE REPORTER HAS RETRAINED THE CLINICIANS.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO THEIR CLINICAL LABORATORY SERVICES PROVIDER, 3 INSTANCES OF CLINIC PERSONNEL BEING SPLASHED IN THE EYE WITH SUREPATH PRESERVATIVE FLUID WITH PAP SAMPLE. THE EVENTS OCCURRED 2 TIMES IN 2008. IN EACH CASE, THE PRACTITIONER WAS ATTEMPTING TO REMOVE THE HEAD OF THE COLLECTION SPATULA WHEN THE SAMPLE WAS SPLASHED. THEY STATED THAT IT WAS "DIFFICULT" TO REMOVE THE HEAD OF THE COLLECTION DEVICE. CLINIC PERSONNEL WERE NOT WEARING RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT. THE SAMPLES WERE NOT KNOWN TO BE POSITIVE FOR ANY INFECTIOUS AGENT, HOWEVER ALL EXPOSED PERSONNEL WERE TREATED WITH PROPHYLAXIS MEDICATIONS AS A PRECAUTION AND WILL BE MONITORED FOR 3-6 MONTHS PER CLINIC POLICY. REFERENCE MW# 1062336-2008-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH COLLECTION KIT CERVICAL CYTOLOGY SAMPLING KIT HHT COOPERSURGICAL, INC. 02500-SC 57148/57149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention