MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" (183CM) APPX 1.4ML, SMALLBORE EXT SET W/ ANTI-SIPHON VALVE, CLAMP, LUER LOC; STOPCOCK, I.V. SET

Catalog Number	B2038
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary when additional reportable information becomes available.
Event or Problem Description
It was reported that regarding a 72" (183cm) appx 1.4ml, smallbore ext set w/ anti-siphon valve, clamp, luer lock that the infusion tubing leaked in two separate cases and also frequently alarmed "obstruction" with infusion pump.Did not happen with the first syringe but once syringe was replaced.There was patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
The complaint of infusion tubing leaked in two separate cases and also frequently alarmed "obstruction" with infusion pump on item b2038 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history record review couldn't be performed due to the lot number for this complaint was unknown.Corrected information can be found in: -d10 - concomitant products.-section e (throughout).-h6 - component code.Additional contacts: (b)(6).

• Brand Name: 72" (183CM) APPX 1.4ML, SMALLBORE EXT SET W/ ANTI-SIPHON VALVE, CLAMP, LUER LOC
• 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; . 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22149895
• Report Number: 9617594-2025-01156
• Device Sequence Number: 7639311
• Product Code: FMG
• UDI-Device Identifier: 00887709002999
• UDI-Public: 00887709002999
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: B2038
• Device Lot Number: UNKNOWN
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 FLUID/INFUSATE, MFR UNK.; UNSPECIFIED SYRINGE, MFR UNK.
• Patient Sex: Unknown