BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE VAGINAL SPECULUM

    MDR report key: 18257637 · Received December 1, 2023

    Report

    Report Number
    MW5148702
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Report Date
    November 30, 2023
    Manufacturer
    TRINITY STERILE, INC.
    Product Code
    HIB
    UDI-DI
    10841767106386
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PACKAGE LABEL FOR TRINITY STERILE'S DISPOSABLE VAGINAL SPECULUM LARGE (ITEM NO. 22202) AND, PRESUMABLY, OTHER SIZES, GIVES THE IMPRESSION THAT THE PRODUCT IS STERILE WHEN IT IS NOT. THE WORD STERILE APPEARS IN VERY LARGE LETTERS AT THE TOP OF THE PACKAGE LABEL (AS PART OF THE BRAND NAME TRINITY STERILE), WHILE THE WORD NON-STERILE APPEARS ONLY IN MINUSCULE LETTERS OFF TO THE SIDE OF THE LABEL IN A TRIANGLE, NEXT TO THE "NO LATEX" AND "SINGLE USE ONLY" ICONS. I CAN TELL YOU THAT THE LABELING LED TO THE MISTAKEN IMPRESSION THAT THIS IS A STERILE SPECULUM, AND IT HAS BEEN USED UNDER THAT ASSUMPTION FOR SOME TIME ON OUR LABOR AND DELIVERY UNIT. WHILE I CANNOT POINT TO A SPECIFIC HARM THAT HAS REACHED A PATIENT, I CAN SAY THAT USING A NON-STERILE SPECULUM HAS THE POTENTIAL, UNDER SPECIFIC CIRCUMSTANCES, TO CAUSE HARM DURING A PREGNANCY, AS WITH PRETERM PREMATURE RUPTURE OF MEMBRANES. THE LABEL SHOULD CLEARLY STATE "NON-STERILE" IN VERY PROMINENT LETTERING, PROXIMATE TO AND MORE POMINENT THAN THE MISLEADING BRAND NAME "TRINITY STERILE," TO REMOVE ANY CONFUSION ABOUT THE STERILITY OF THIS SPECULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065642 DISPOSABLE VAGINAL SPECULUM SPECULUM, VAGINAL, NONMETAL HIB TRINITY STERILE, INC. 22202 54577 10841767106386

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown