MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33038
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event involved a 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing.The complaint report stated that at the j-loop (attached to iv catheter), blood came out of the tubing from the blue part (at the connection site that attaches to the end), because the connection piece was cracked.This occurred during a blood draw after connection was made, blood pooled onto the floor.The staff subsequently flushed and cleaned out the faulty j-loop.The sample photo was provided showing the j-loop with blood and when it was flushed and cleaned out.There was no patient harm or adverse event as a consequence of this complaint/event.
Additional Manufacturer Narrative
One (1) photo confirms the complaint of the blood started pooling out of tubing either in the blue part attaching to the end or the tubing is cracked.The customer complaint can be confirmed from the photograph provided.A probable cause cannot be identified based on the information that has been provided.Lot history review was reviewed, and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC
• 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: 21152345
• Report Number: 9617594-2025-00091
• Device Sequence Number: 9134143
• Product Code: FPA
• UDI-Device Identifier: 00887709037281
• UDI-Public: (01)00887709037281(17)290801(10)14121331
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: MC33038
• Device Lot Number: 14121331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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
• Patient Sex: Unknown