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	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18 cm) smallbore pressure infusion (400psig) ext set w/remv microclave® clear, clamp, nanoclave® t-connector (purple ring), rotating luer where the customer reported that the connector extension leaked normal saline (baxter) when attempting to flush iv line.Additionally, upon connection to closer t portion into the connector, it would still leak as side portion.The event occurred during uv flush.There was patient involvement and no human harm.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
Received one (1) used a1129 smallbore pressure infusion ext set for inspection.A crack was observed on the female luer.The reported complaint of leakage can be confirmed due to the crack found.The probable cause is due to a material issue on a vendor supplied part.A device history lot # review could not be conducted because no lot number(s) was/were identified.D9 device returned to the manufacturer on 4/22/2025 corrective actions are in process.

• 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: 21962613
• Report Number: 9617594-2025-00907
• Device Sequence Number: 17969594
• 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): 06/27/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE, BAXTER
• Patient Sex: Unknown