MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.44 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®,; STOPCOCK, I.V. SET

Catalog Number	B33540
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date is unknown.1 jan 2024 has been used as a place holder.The event was report to icu medical through the following contact: reporter facility name: (b)(6).Reporter name: (b)(6).Reporter address: (b)(6).Reporter email: (b)(6).Reporter phone number:(b)(6).Brand name - 4" (10 cm) appx 0.44 ml, smallbore trifuse ext set w/3 microclave®, 3 clamps (red, white, blue), rotating luer.
Event or Problem Description
On an unknown date the event involved is 4" smallbore trifuse ext set w/3 microclave® clear, 3 clamps, rotating luer that experienced air in line which required ultra-sound medical intervention.The reporter stated that ¿after filling the extensions with salt before use and connecting them to the child, air bubbles appear in the fluid path.In several cases, the bubble was found during ultrasound in the child's vein¿.There was patient involvement, but unknown human harm.
Additional Manufacturer Narrative
Investigation summary: no 011-mc33029 product samples, videos or photographs were returned for investigation.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 4" (10 CM) APPX 0.44 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®,
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19930131
• Report Number: 9617594-2024-01084
• Device Sequence Number: 2760625
• Product Code: FMG
• UDI-Device Identifier: 00887709055780
• UDI-Public: 00887709055780
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: B33540
• Device Lot Number: 13890272
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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: UNSPECIFIED DRUG , MFR UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown