MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX EXTENSION SETS SINGLE LINE; 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	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the lipid filter was leaking while connected to picc line.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn xxxxxxxx-2025-00xxx for details pertinent to this event.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: received one (1) used list# mx448hfb, non-dehp ext set 1.2 micron filter.As received, there were no damages or anomalies observed.The sample was leak tested at 20 psi using a hydrostatic pressure pump.A leak was observed at the second air filter outlet before the outlet tubing.The complaint of leakage can be confirmed.The probable cause is due to the filter's loss of hydrophobic properties.A device history record could not be completed as no lot number was received.

• Brand Name: MEDEX EXTENSION SETS SINGLE LINE
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21357188
• Report Number: 9616567-2025-00028
• Device Sequence Number: 8563789
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: (01)10351688507457
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2025

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: Other
• Device Catalogue Number: MX448HFB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 01/17/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/10/2025; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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