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	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation summary received one (1) used list# a1129 smallbore pressure infusion ext set w/remv microclave® clear, clamp, nanoclave® t-connector (purple ring), rotating luer.As received, the a crack was visible down the side of the female luer as it was attached to the microclave.The set was tested as per specification and leaking from the crack on the female luer was confirmed.A dhr lot and relevant commodities were reviewed, the following discrepancy was identified: exception type: ncmr lot#: 13873977, 13645808, 5775140 discrepancy: "during visuals inspection on molding qa found broken insert on cavity a54.After bracketing totes 23-28 were affected." " a2 quality found cuts in silicone on inner diameter of plug in start up of lot # 13667981" "during routine molding visual inspection, mqa inspector found loose debris.Bags 4-8 are affected.Bags 1-3 are also affected." the complaint of leaking and breakage can be confirmed.The probable cause of the crack is unknown.
Event or Problem Description
A complaint was received regarding 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 that experienced breakage and leakage.This is report 1 of 2.It was stated in the report that once of my customers is experiencing leaking and injection ports are breaking; dr.Stated that the t-connector the patient came with from the cicu was broken.The replacement also broke, this time it¿s the injection port closest to the hub connected to the piv that broke.There was patient involvement, and no patient were harmed but there was a delay in therapy.

• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21334652
• Report Number: 9617594-2025-00237
• Device Sequence Number: 3826102
• Product Code: FPA
• UDI-Device Identifier: 00887709068193
• UDI-Public: (01)00887709068193(17)290601(10)14049374
• 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
• Report Date (Section B): 02/07/2025

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: 14049374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2024
• 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
• Patient Sex: Unknown