MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33038
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date and involved a 7" (18 cm) appx 0.41 ml, pressure infusion (400psig) ext set w/remv microclave¿ clear, purple clamp, luer lock where the customer reported that the device was defective/broken at the female luer.The incident occurred 2 times.There was unknown patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The actual device was not returned for evaluation, however, the reported complaint of a broken luer can be confirmed based on the complaint reported condition and device information; the probable cause is due to a material issue on a vendor supplied part.A corrective action is in process.Lot history review was unable to be conducted as the lot number was not provided.

• Brand Name: 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC
• 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: 21970823
• Report Number: 9617594-2025-00917
• Device Sequence Number: 8160724
• Product Code: FPA
• UDI-Device Identifier: 00887709037281
• UDI-Public: 00887709037281
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: MC33038
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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