MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.67 ML, EXT SET PRESSURE INFUSION (400 PSIG) W/2 MICROCLAVE¿ CL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC330623
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 9" (23 cm) appx 0.67 ml, ext set pressure infusion (400 psig) w/2 microclave¿ clear, purple clamp, rotating luer where it was reported that during the intravenous (iv) contrast injection, the contrast flowed through the clamp off second lumen out onto the patient.The valve broke and the rubber/silicon piece sticking outside of hub.The purple clamp was closed.The injection of contrast was going into the unclamped lumen.The pressure caused the contrast to flow up through the other clamped off lumen and forced the rubber valve to pop out of iv.The contrast/liquid then flowed all over the patient into the computed tomography (ct) table.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Additional Manufacturer Narrative
Two (2) samples (1 new and 1 used) list# mc330623, 9" (23 cm) appx 0.67 ml, ext set pressure infusion (400 psig) w/2 microclave¿ clear, purple clamp, rotating luer were returned for evaluation.As received, the silicone seal of the used samples was observed to be protruding out of shuntless, no additional damages were observed.The brand new set was opened and no visually abnormalities were confirmed.The bran new sample was high pressure tested with an activated clamp, after the test the seal popped out.No additional damage or anomalies were observed.The od and id of the tubes were measured finding within specification, however when the pinch clamp's gap was measured, this was found out of specifications.The sample was sent to manufacturing sites and after some test, they confirmed the clamp met the product specification.Complaint can be confirmed.The probable cause is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 9" (23 CM) APPX 0.67 ML, EXT SET PRESSURE INFUSION (400 PSIG) W/2 MICROCLAVE¿ CL
• 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: 21742812
• Report Number: 9617594-2025-00614
• Device Sequence Number: 11789369
• Product Code: FPA
• UDI-Device Identifier: 00887709097667
• UDI-Public: 00887709097667
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: MC330623
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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
• Patient Sex: Unknown