MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CONTINUOUS EPIDURAL TRAY

Catalog Number	PAIN2011
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "had the catheter come apart from the connector twice and the filter come apart from the connector twice.One of each was on the same patient.The filter itself does not leak.It is the connection to the connector that is the problem.The locking mechanism loosens very easily causing a leakage at that junction or it can come detached completely.I once had a leak that i didn't notice and had dosed duramorph.Then noticed a wet spot on the patient's pillow.Had no clue as to whether the patient received the dose or not.I had to assume that it leaked and re dosed the patient.1 error on that side vs not re dosing and exposing the patient to more pain due to not getting the medication".A 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.
Event or Problem Description
According to the customer, "had the catheter come apart from the connector twice and the filter come apart from the connector twice.One of each was on the same patient.The filter itself does not leak.It is the connection to the connector that is the problem.The locking mechanism loosens very easily causing a leakage at that junction or it can come detached completely.I once had a leak that i didn't notice and had dosed duramorph.".

• Common Device Name: CONTINUOUS EPIDURAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19259637
• Report Number: 1417592-2024-00576
• Device Sequence Number: 6614372
• Product Code: OFT
• UDI-Device Identifier: 40195327509737
• UDI-Public: 40195327509737
• 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
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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 Catalogue Number: PAIN2011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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