MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET¿ SHIELDED BLUNT CANNULA; CATHETER, CONTINUOUS FLUSH

Catalog Number	423030402
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a safeset shielded blunt cannula, and it was reported that there were issues when drawing blood from the transducers.Specifically, blood drips on the blue piece were noted, directly where the blood collection adapter is connected to the shielded blunt cannula.Also, air going into the actual blood collection tube was noted when this happens.There was patient involvement, and no patient harm.
Additional Manufacturer Narrative
D9 - date returned to mfr: 3/17/2026.The reported complaint of leak was not confirmed on the returned sets.A blunt cannula will not be connected to that cord.No visual anomalies were observed on the returned sets.When the blunt cannula is connected to a monitoring kit and when fluid was drawn, no leaks were observed near the blunt cannula.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: SAFESET¿ SHIELDED BLUNT CANNULA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 24466424
• Report Number: 9617594-2026-00201
• Device Sequence Number: 9581146
• Product Code: KRA
• UDI-Device Identifier: 00840619044169
• UDI-Public: (01)00840619044169(17)301101(10)14769183
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K932188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 423030402
• Device Lot Number: 14769183
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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: BLOOD COLLECTION ADAPTOR, CARDINAL HEALTH.; TRANSDUCER SET, ICU MEDICAL INC.
• Patient Sex: Unknown