MAUDE Adverse Event Report: ICU MEDICAL, INC. SMALL BORE STOPCOCKS; STOPCOCK I.V. SET

Catalog Number	MX5341L
Medical Device Problem Codes	Backflow (1064); Disconnection (1171)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during routine patient care a small-bore stopcock had an issue involving intravenous line connections.Upon assessment prompted by observed low blood pressure readings, it was discovered that the sedation line had become disconnected.Approximately 10 ml of blood was noted on the patient¿s bed at the time of discovery.The site representative ensured all lines were inspected and resecured appropriately and new stopcocks were primed and connected to maintain proper line integrity.Sedation and epinephrine therapy was being administered during the event.The patient had decreased blood pressure and needed another linen change and there was loss of blood volume at time of occurrence.Further, the patient was stabilized once stopcock was replaced.There was patient involvement, and no harm.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.D4 - primary udi number: only di provided as lot number is unknown.

• Brand Name: SMALL BORE STOPCOCKS
• Common Device Name: STOPCOCK I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 25302422
• Report Number: 1526863-2026-00114
• Device Sequence Number: 15794874
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: (01)10351688506788
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: Lay User/Patient
• Device Catalogue Number: MX5341L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: EPINEPHRINE, UNK MFR.
• Patient Sex: Unknown