MAUDE Adverse Event Report: TRINITY STERILE, INC. DISPOSABLE VAGINAL SPECULUM; SPECULUM, VAGINAL, NONMETAL

Model Number	22202
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: DISPOSABLE VAGINAL SPECULUM
• Common Device Name: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): TRINITY STERILE, INC.
• MDR Report Key: 18257637
• Report Number: MW5148702
• Device Sequence Number: 7840688
• Product Code: HIB
• UDI-Device Identifier: 10841767106386
• UDI-Public: (01)10841767106386(11)220915(10)54577(17)250914
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Model Number: 22202
• Device Catalogue Number: 22202
• Device Lot Number: 54577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown