MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33213
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2025 has been used as a placeholder.Investigation summary: received one (1) used partial mc33213 smallbore pressure infusion (400 psig) ext set; lot #13848519, one (1) used partial mc33213 smallbore pressure infusion (400 psig) ext set; lot #14279809, one (1) used mc33213 smallbore pressure infusion (400 psig) ext set; lot #unknown, and one (1) used mc33213 smallbore pressure infusion (400 psig) ext set; lot #14371632.Lot #13848519 crack at the female luer r1-2361.Lot #14279809 crack at the female luer r1-2361.Unknown lot number crack at the female luer r1-2361.Lot #14371632 no defects or anomalies noted on the female luer or anywhere on the set.Each set was leak tested per product specifications.There was no leakage on the mc33213 lot #14371632.There was leakage on the other three (3) sets from the cracks on the female luers.The reported complaint can be confirmed on three (3) of the returned sets.The probable cause of the cracks and subsequent leakage is due to a material issue on a vendor supplied part.The provided lot numbers were reviewed; no nonconformities were identified that may have contributed to the reported complaint.Corrective and preventative actions are in process.
Event or Problem Description
Event occurred on an unspecified date regarding 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer where the report state "crack hub and leaking at the connection of the microclave to the extension set.Report captures 3 occurrences.There were unknown patient involvement and unknown adverse event.

• Brand Name: 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI
• 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: 22963454
• Report Number: 9617594-2025-01793
• Device Sequence Number: 18275065
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: 00887709037519
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: MC33213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/04/2025
• 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