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	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 14" ext set w/0.2 micron filter, clave® clear, clamp, rotating luer where the reporter stated that when doing ¿idc¿ (understood to be invasive ductal carcinoma) droplets were seen coming from the micron filter on the lower right-hand side.The customer stated that the healthcare professional put on personal protective equipment (ppe) and treated as chemo spill.The patient had one droplet on shirt and changed into a hospital shirt.There was patient involvement, a delay in therapy, but there was no harm reported as a result of this event.
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
Received one (1) used list# mc9013, 14" ext set w/0.2 micron filter, clave® clear, clamp, rotating luer; lot# unknown the filter was observed to be wetted out.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed on the inline filter.The probable cause of the leak is from the temporary loss of hydrophobic properties.A device history lot# review could not be conducted because no lot number(s) was/were identified.D9 device returned to manufacturer on 6/9/2025.

• 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: 22163430
• Report Number: 9617594-2025-01165
• Device Sequence Number: 7273880
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 08/10/2025
• 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: CHEMO DRUG, UNSPECIFIED.
• Patient Sex: Unknown