MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.43 ML, SMALLBORE BIFUSE PRESSURE INFUSION (400 PSIG) EXT SET W; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC330147
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report number mw5183164 was received a complaint regarding the following device: 9" (23 cm) appx 0.43 ml, smallbore bifuse pressure infusion (400 psig) ext set w/2 microclave® clear, 2 purple clamps, rotating luer.It was stated in the report that the rn bedside to a 4-year-old male black or african american noticed leaking from the connection site between the primary tubing of lipids and y-site connecting to the pt central line.On their further assessment, they could see fluids coming from crack in cap.The y-site was removed and a new one connected to the patient.There was no report of any human harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.If a return or any additional information is later received, then a supplemental emdr will be submitted at that time.

• Brand Name: 9" (23 CM) APPX 0.43 ML, SMALLBORE BIFUSE PRESSURE INFUSION (400 PSIG) EXT SET W
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24605921
• Report Number: 9617594-2026-00279
• Device Sequence Number: 10338091
• Product Code: FPA
• UDI-Device Identifier: 00887709078895
• UDI-Public: 00887709078895
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: MC330147
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: LIPIDS, MFR UNK.; PATIENT CENTRAL LINE, MFR UNK.; UNSPECIFIED PRIMARY LINE, MFR UNK.
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Race: Black Or African American