MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave®, 0.2 Micron Filter, Cl; Stopcock, I.V. Set

Catalog Number	A1186
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involving an 8.5" (22 cm), approximately 0.57 ml, smallbore extension set with nanoclave, 0.2 micron filter, clamp, and rotating luer occurred while a patient was receiving a chemotherapy infusion.Upon initiation of the medication, air in the line was observed.The line was back primed and the infusion was restarted.When the infusion was almost complete, air in the line was observed again.The line could not be reprimed, and the medication was returned to the pharmacy for a new filter.A different brand and lot of filter was placed on the line, and the infusion was completed.There were patient involvement and no reported patient harm.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.

• Brand Name: 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave®, 0.2 Micron Filter, Cl
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50808407
• Report Number: 9617594-2026-01297
• Device Sequence Number: 8653165
• Product Code: FMG
• UDI-Device Identifier: 00887709077874
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: A1186
• Device Lot Number: 14861710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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