MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; CSE TRAY

Model Number	PAIN1808
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility an epidural catheter was initially placed without complications.Per the facility after assessing the catheter, local anesthetic was not administered due to high-resistance in the catheter.Per the facility the catheter was redrawn 1 cm and the connector to the catheter was replaced with no further success.Per the facility after removing the catheter from the patient, the catheter was noted to have "significant resistance with minimal solution reaching the distal 1 cm of the catheter".No additional information is available at this time.The sample has not been 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 an epidural catheter was initially placed without complications.Per the facility after assessing the catheter, local anesthetic was not administered due to high-resistance in the catheter.

• Brand Name: Medline Industries, Inc.
• Common Device Name: CSE TRAY
• 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: 16564610
• Report Number: 1417592-2023-00110
• Device Sequence Number: 14827249
• Product Code: OFT
• UDI-Device Identifier: 10195327145446
• UDI-Public: 10195327145446
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: PAIN1808
• Device Catalogue Number: PAIN1808
• Device Lot Number: 22JLA166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/17/2023
• 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