MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DBD-D&C

Model Number	DYNJ34432I
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2020, while prepping a patient for a hysteroscopy dilation and curettage (d/c) after prepping the vagina with a betadine sponge stick, the registered nurse (rn) "pulled it out and the sponge had detached and remained in the vagina." the reporter states, "the surgeon had to remove the sponge portion of it prior to the start of the case.There was no report of serious injury.However due to medical intervention and in abundance of caution this medwatch is being filed.There are no samples or photos available for return and evaluation.Investigation summary reads as follows: unfortunately, without a sample or photo we are unable to confirm the issue and determine a root cause.No further information is available at this time.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported; the sponge had detached from the stick and remained in the vagina after prepping the patient for surgery.The surgeon had to remove the sponge portion of the sponge stick prior to the start of the case.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: DBD-D&C
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10876336
• Report Number: 1423395-2020-00031
• Device Sequence Number: 16509348
• Product Code: OKV
• UDI-Device Identifier: 10193489224696
• UDI-Public: 10193489224696
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: DYNJ34432I
• Device Catalogue Number: DYNJ34432I
• Device Lot Number: 20DBT586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/20/2020
• 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: Required Intervention
• Patient Weight: 77