MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; TRAY,CON,EPID,19G REINF,W/TUOH

Model Number	PAIN9025
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	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2023 "the patients epidural catheter became dislodged from the hub at the connector and the epidural was replaced as parts of the epidural catheter looked to be disintegrated.".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 "the patients epidural catheter became dislodged from the hub at the connector and the epidural was replaced as parts of the epidural catheter looked to be disintegrated".Per the facility the patient was later converted to general anesthesia and was later discharged on (b)(6) 2023 without further incident.No additional information is available at this time.Sample is not available 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.

• Brand Name: Medline Industries, Inc.
• Common Device Name: TRAY,CON,EPID,19G REINF,W/TUOH
• 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: 16736621
• Report Number: 1417592-2023-00166
• Device Sequence Number: 6843899
• Product Code: OFT
• UDI-Device Identifier: 10193489777697
• UDI-Public: 10193489777697
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/13/2023

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: PAIN9025
• Device Catalogue Number: PAIN9025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/13/2023
• 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