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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation however a device history review should be performed, and a supplemental report will be submitted.Additional contact information: (b)(6) canada.
Event or Problem Description
The event involved a 72" (183cm) appx 1.4ml, smallbore ext set w, anti-siphon valve, clamp, luer lock and it was reported that the tubing often led to developing a hole and the patient received less drug.One patient was having brain surgery, his head was pinned, and he started to move because he was not getting enough drug, the medication involved in the event is propofol, norepinephrine and narcotics (remi and suf).The event occurred after infusion is started.Impact on patient was code 3 which includes actual, potential adverse outcome and moderate injury requiring medical treatment.There was patient involvement, and no patient harm.The event occurred on two different dates, and this report captures the second of the two event dates.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The device history record was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• 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; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24797556
• Report Number: 9617594-2026-00351
• Device Sequence Number: 9469655
• Product Code: FMG
• UDI-Device Identifier: 00887709002999
• UDI-Public: (01)00887709002999(17)300901(10)14565772
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: B2038
• Device Lot Number: 14565772
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2025
• 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: NOREPINEPHRINE, UNK MFR.; PROPOFOL, UNK MFR.; REMI, UNK MFR.; SUF, UNK MFR.
• Patient Sex: Unknown