MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) EXT SET W/1.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC330310
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint/event involved a 14" (36 cm) ext set w/1.2 micron filter, microclave® clear, clamp, rotating luer.The reporter stated that she clamped the total parenteral nutrition (tpn) at the quadfuse and attempted to begin infusing the lipids on the pump.The lipids never infused through the cap into the quadfuse.Upon unclamping the tpn, it immediately back-flowed back up into the lipid tubing.There was no patient harm, but the patient did not receive the full doses of prescribed lipids.
Additional Manufacturer Narrative
Additional information: the probable cause was clarified in an updated device evaluation.Investigation summary one (1) used list# mc330310, connected to an unknown, y-extension set, an unknown, 250ml iv bag and an unknown, infusion set were returned for evaluation.As received, some lipids solution residuals were observed.A filter saturation on filter, 1.2 micron was observed, no additional damage or anomalies were found.The set was tested as per procedure and a flow restriction was confirmed.Complaint of back flow of fluid / bleedback can be confirmed.The probable cause was due to a filter saturation.According dfu - ivfe or tna (3-in-1) solutions containing lipids must be administered using a 1.2-micron filter.Sets with these filters should be changed at least every 24-hours.A filter that clogs during infusion should be replaced.A dhr lot# review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
One (1) used list# mc330310, connected to an unknown, y-extension set, an unknown, 250ml iv bag and an unknown, infusion set were returned for evaluation.As received, some lipids solution residuals were observed.A filter saturation on filter, 1.2 micron was observed, no additional damage or anomalies were found.The set was tested as per procedure and a flow restriction was confirmed.Complaint of backflow of fluid / bleedback can be confirmed.According to the directions for use solutions containing lipids must be administered using a 1.2-micron filter.Sets with these filters should be changed at least every 24-hours.A filter that clogs during infusion should be replaced.A device history review (dhr) lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 14" (36 CM) EXT SET W/1.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21145830
• Report Number: 9617594-2025-00083
• Device Sequence Number: 18474153
• Product Code: FMG
• UDI-Device Identifier: 00887709083189
• UDI-Public: (01)00887709083189
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

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: MC330310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/03/2025; 03/05/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/03/2025; 03/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TPN, MFR UNK.
• Patient Sex: Unknown