MAUDE Adverse Event Report: BECTON DICKINSON AND CO / CAREFUSION 2200, INC. D DRY PREOPERATIVE SKIN PREP TRAY; SKIN PREP TRAY

Model Number	4461A
Health Effect - Clinical Codes	Erythema (1840); Abnormal Vaginal Discharge (2123); Discomfort (2330); Foreign Body In Patient (2687); Swelling/ Edema (4577)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
In preparation for a c-section, the rn performed a vaginal cleanse using the bd skin prep tray.She soaked the sponge sticks (2) in betadine and put two together and inserted them into pt's vagina.She waited 15 seconds and then removed both sponge sticks and disposed of them into the basin at the base of pt's vagina and threw them away.The patient had an epidural so did not feel anything.The physician performed a fundal massage at the end of the procedure and the usual amount of vaginal discharge/blood was seen coming from the vagina without anyone seeing the sponge which had become dislodged from one of the sticks and remained in the vagina.The patient was discharged on (b)(6) 2020 w/o complaint of vaginal pressure, pain, or odor.The patient had been seen by an outpatient health provider via tele-video and reported having some ongoing labia swelling and discomfort but declined to make an appointment at that time ((b)(6) 2021).On (b)(6) 2021, the pt called her provider's clinic and asked to make an appointment as she was now feeling some pressure in her vaginal area and smelling a strong odor.The provider asked if had pain she denied but she did report she felt into her vagina and felt what seemed to be a sponge.The provider told her to go ahead and remove it if she felt comfortable doing so.The patient removed the sponge and brought it to her doctor's office the next day (b)(6).Her exam showed some redness, no fever, chills, pain, min.Discharge.No meds prescribed.Fda safety report id# (b)(4).

• Brand Name: D DRY PREOPERATIVE SKIN PREP TRAY
• Common Device Name: SKIN PREP TRAY
• Manufacturer (Section D): BECTON DICKINSON AND CO / CAREFUSION 2200, INC. ; vernon hills IL 60061
• MDR Report Key: 11343308
• Report Number: MW5099454
• Device Sequence Number: 4069137
• Product Code: OJU
• UDI-Device Identifier: 10885403142192
• UDI-Public: (01)10885403142192
• Initial Reporter State: CO
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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 Model Number: 4461A
• Device Catalogue Number: 4461A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Weight: 93