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

Model Number	PAIN1667A
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	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, 'a patient had her epidural running and was not getting comfortable'.Per the facility, 'we found that the connector was cracked, and the medication was coming out and not getting to the patient'.
Additional Manufacturer Narrative
According to the facility, 'a patient had her epidural running and was not getting comfortable'.Per the facility, 'we found that the connector was cracked, and the medication was coming out and not getting to the patient'.The sample is not available to be returned for evaluation.No additional information is available at this time.Due to the reported incident and 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: CONTINUOUS EPIDURAL 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: 15620303
• Report Number: 1417592-2022-00195
• Device Sequence Number: 17757564
• Product Code: OFT
• UDI-Device Identifier: 10193489472868
• UDI-Public: 10193489472868
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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: PAIN1667A
• Device Catalogue Number: PAIN1667A
• Device Lot Number: 22FLB089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/17/2022
• 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: Required Intervention
• Patient Sex: Female