MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC MEDEX EXTENSION FILTER SETS; FILTER, INFUSION LINE

Catalog Number	MX448HFB
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number 9616567-2025-00031-00.The date of that submission was 17-feb-2025.Device was received for analysis.Visual and functional evaluation was performed a crack was observed on the female luer of the filter, along the parting line.A leak was observed at the female luer connection from the crack previously observed.The leak was observed to start at 0.5 psi.Complaint was confirmed.The causal factor of failure mode crack at the female port of the blue filter was related to a mishandling of the product.Device history review found no discrepancies or anomalies were observed during the manufacturing of this lot.
Event or Problem Description
It was reported that lipids started leaking where the regular iv tubing meets the lipid filter on a pcvc line.Also, the lipids leaked at connection between regular baxter iv tubing and medex micron lipid filter.There were unknown patient harms or adverse events reported as a result of the event.

• Brand Name: MEDEX EXTENSION FILTER SETS
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22070349
• Report Number: 1526863-2025-00058
• Device Sequence Number: 20932081
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: (01)10351688507457(17)270701(10)6020860
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX448HFB
• Device Lot Number: 6020860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown