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
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.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.
Additional Manufacturer Narrative
E1 - this complaint was received through: (b)(6).The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary: 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.As received, no signs of physical damage or cracks, no other anomalies observed.No mating device was returned for evaluation.The set was tested as per procedure and no leaks were observed the complaint of leaking issues with t-connector cannot be confirmed.The lot history was reviewed, 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21335004
• Report Number: 9617594-2025-00239
• Device Sequence Number: 8624212
• Product Code: FPA
• UDI-Device Identifier: 00887709068193
• UDI-Public: (01)00887709068193(17)290801(10)14095918
• 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): 03/19/2025

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: 14095918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/19/2025
• 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