MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 60" Smallbore Ext Set w/MicroClave® Clear, Clamp, Luer Lock; stopcock, i.v. set

Catalog Number	MC33352
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involved a smallbore extension set with a micro clave clear connector.It was reported that, a dose of ceftaroline was connected to the extension set; however, the medication could not be flushed through the tubing.A second extension set was used, but the medication still could not be flushed.An extra dose of ceftaroline pulled from patient's med drawer and connected to other extension set, after which the medication was successfully flushed.There was patient involvement; however, no patient harm or injury was reported.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.

• Brand Name: 60" Smallbore Ext Set w/MicroClave® Clear, Clamp, Luer Lock
• 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: 50899756
• Report Number: 9617594-2026-01346
• Device Sequence Number: 20333877
• Product Code: FMG
• UDI-Device Identifier: 00887709038004
• UDI-Public: (01)00887709038004(17)310301(10)14907090
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2026

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: MC33352
• Device Lot Number: 14907090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Ceftaroline, unk mfr
• Patient Sex: Unknown