MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC9013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint/event involved a 14" ext set w/0.2 micron filter, clave® clear, clamp, rotating luer.The reporter stated that, during injection of a radioactive tracer during the stress portion of a myocardial perfusion imaging (mpi stress) test, the patient's patent foramen ovale (pfo) filter malfunctioned and ruptured.Unspecified tracer leaked and landed on the ecg tech and the patient.All involved and the area needed to be decontaminated and the patient needed to have the procedure redone.The leak was right at the rectangle of the filter.There was unexpected or prolonged care.There was no report of any specific human harm associated with this complaint/event.
Additional Manufacturer Narrative
Received a photo from the customer.No conclusions could be made from the provided photo.One used list# mc9013, 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer; lot# unknown --> one used list# unknown, micro clave; lot# unknown.The filter was observed to have some cold form damage.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed on the side of the filter.The probable cause is from an external force during use leading to a crack.The device history record could not be reviewed because no lot number was identified.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• 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: 21607649
• Report Number: 9617594-2025-00476
• Device Sequence Number: 18460382
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: 00887709039391
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: MC9013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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: PATENT FORAMEN OVALE (PFO) FILTER, MFR UNK; UNSPECIFIED IMAGING EQUIPMENT, MFR UNK; UNSPECIFIED RADIOACTIVE IMAGING TRACER, MFR UNK
• Patient Sex: Unknown