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

Model Number DYNJ34432I

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

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 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.
• Type of Device: DBD-D&C
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 10876336
• MDR Text Key: 228433125
• Report Number: 1423395-2020-00031
• Device Sequence Number: 1
• Product Code: OKV
• UDI-Device Identifier: 10193489224696
• UDI-Public: 10193489224696
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ34432I
• Device Catalogue Number: DYNJ34432I
• Device Lot Number: 20DBT586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 77