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	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved 14" ext set with 0.2 micron filter, clave clear, clamp, rotating luer.It was reported that the patient placed supine to boost up in bed for scheduled cxr.After patient was sat back up, blood noted to have backed up from the cvc into the medication and vasopressor lines (there was a filter attached to the line).Patient became hypotensive, additional vasopressors administered and patient stabilized.It appears that lines with the filter attached were more prone to this issue.The event occurred during infusion.There was a patient involvement and no patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.E1 - initial reporter phone and email is unknown.(b)(6).

• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50729772
• Report Number: 9617594-2026-01247
• Device Sequence Number: 13411752
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: (01)00887709039391
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: MC9013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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