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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 14" (36 cm) ext set w/1.2 micron filter, microclave® clear, clamp, rotating luer.A leak was reported from the port on the lipid tubing directly below light blue alcohol cap.The infusion line was stopped and the tubing was disconnected.Upon disconnecting the infusion line at the blue cap site prior to flushing, the nurse noticed the hub on the cap that connected to the patient (not on tubing, on dark blue bifurcated extension) did not lay flush.As such, if one were trying to scrub the hub there was an indent and it was not flat.There was no patient harm, but the patient did not receive the full dose of prescribed lipids.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
One used list# mc330310, 14" (36 cm) ext set w/1.2 micron filter, microclave¿ was returned for evaluation.As received, some lipids solution residuals were observed, no additional damage or anomalies were found.The set was tested as per procedure and no leaks or anomalies were confirmed.Complaint of leak cannot be confirmed or replicated.A device history 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: 21145918
• Report Number: 9617594-2025-00085
• Device Sequence Number: 9190210
• 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
• Report Date (Section B): 02/28/2025

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
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/28/2025
• 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: UNSPECIFIED LIPIDS INFUSATE, MFR UNK
• Patient Sex: Unknown