BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1506 - PF VIPER 10M

    MDR report key: 1363378 · Received January 28, 2009

    Report

    Report Number
    1216735-2009-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2009
    Date of Event
    December 9, 2008
    Report Date
    January 22, 2009
    Manufacturer
    PURITAN MEDICAL PRODUCTS COMPANY LLC
    Product Code
    KXF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN PREVIOUSLY REPORTED AS 1119779-2009-0001. THE MANUFACTURING EQUIPMENT, PRODUCTION RECORDS, AND RETENTION SAMPLES FROM THE SUBJECT LOTS WERE UNREMARKABLE. THIS EVENT IS REPORTED FROM (B) (4) APPLICATORS MARKETED IN THE LAST THREE YEARS. NO ROOT CAUSE WAS IDENTIFIED BY THE INVESTIGATION. THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED AND THE REPORT IS RECORDED, AND WILL BE ANALYZED FOR TRENDING.

    Description of Event or Problem · 1

    DURING SAMPLE COLLECTION BY A NURSE MIDWIFE ON (B) (6) 2008, THE FOAM TIP OF THE SWAB CAME OFF INSIDE THE PATIENT WHILE COLLECTING AN ENDOCERVICAL SPECIMEN. THE MIDWIFE INSERTED THE SWAB AND TWISTED IT AROUND, AS SHE NORMALLY DOES, AND WHEN SHE WENT TO PULL OUT THE SWAB, THE TIP WAS MISSING. THE PATIENT WAS SENT FOR A HYSTEROSCOPY AND D&C WAS PERFORMED. THE SWAB TIP COULD NOT BE LOCATED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1506 - PF VIPER 10M ABSORBENT TIPPED APPLICATOR KXF PURITAN MEDICAL PRODUCTS COMPANY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other