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 Codes	Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/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.At 12:53pm, because the infusion pump alarmed for 'downstream occlusion', the infusion was stopped.The main line was checked for kinks and there were none.The line was disconnected from t-connector, to flush the iv in right ac (an intravenous line in the right antecubital fossa), and medication (renflexis) sprayed the nurse's left forearm, the patient's glasses and shirt as if there was backflow.Upon flushing the iv, the patient stated that he felt pain and the nurse not able to get blood return.The iv was discontinued, no swelling or redness noted, and warm packs were applied.A new iv was placed, via us (ultrasound guidance), in left forearm.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Received one (1) used.List #a1129, 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; lot #14175775.No visual damages or anomalies were observed.The reported complaint of an occlusion could not be confirmed.The returned sample was tested and met product specifications.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 22132213
• Report Number: 9617594-2025-01140
• Device Sequence Number: 8526450
• Product Code: FPA
• UDI-Device Identifier: 00887709068193
• UDI-Public: (01)00887709068193(17)291001(10)14175775
• 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): 07/21/2025

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: 14175775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: INFUSION PUMP, MFR UNK.; MAIN IV LINE (RIGHT AC). MFR UNK.; RENFLEXIS, MFR UNK.
• Patient Sex: Male