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	A1129
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.Photo samples were provided and will be evaluated.
Event or Problem Description
The event involved a 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, clamp, nanoclave® t-connector (purple ring), rotating luer where the customer reported that the iv connector blew out the other side while clamped and leaked (non chemo), during patient use/fluid flush.Patient status was healthy before, during, after reported issue.There was a delay in therapy but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint of a leak could be confirmed from the photos provided.The seal was observed to be popped out of the microclave.However, without the return of the sample a comprehensive review cannot be performed and a probable cause cannot be determined.Lot history review could not be performed as no lot number was received.

• 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: 21972937
• Report Number: 9617594-2025-00922
• Device Sequence Number: 7227695
• Product Code: FPA
• UDI-Device Identifier: 00887709068193
• UDI-Public: 00887709068193
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• 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: A1129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• 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