MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave®, Clamp, Rotating Luer; Stopcock, I.V. Set

Catalog Number	B3302
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involved a smallbore extension set with a micro clave connector.It was reported that peripheral intravenous line demonstrated brisk blood return and flushed without pain.A saline infusion was administered at 60 ml/hour without issue; however, when the infusion rate was increased to 500 ml/hour, the pump generated an occlusion alarm.Inspection of the extension set found that the internal plunger remained in a depressed position.The affected set was removed and replaced with a set from a different lot, after which the infusion proceeded without further issue.There was patient involvement; however, no patient harm or injury was reported.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.

• Brand Name: 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave®, 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: 50773032
• Report Number: 9617594-2026-01262
• Device Sequence Number: 18509534
• Product Code: FMG
• UDI-Device Identifier: 00840619045630
• UDI-Public: (01)00840619045630(17)310501(10)14942434
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: B3302
• Device Lot Number: 14942434
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2026
• 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