MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; GV CAROTID PACK

Model Number	DYNJ46582G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 during a "carotid" procedure a portion of the drape came loose and had to be removed from inside the patient.Per the facility they were able to "pick it out" without impact or injury to the patient.Per the facility the "drape was clamped" when the reported incident occurred.No additional information is available at this time.The sample is not available to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2023 during a "carotid" procedure a portion of the drape came loose and had to be removed from inside the patient.

• Brand Name: Medline Industries, Inc.
• Common Device Name: GV CAROTID PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16630989
• Report Number: 1423395-2023-00014
• Device Sequence Number: 17537178
• Product Code: OEZ
• UDI-Device Identifier: 10195327093983
• UDI-Public: 10195327093983
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ46582G
• Device Catalogue Number: DYNJ46582G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown