MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1415
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding a 6" (15 cm) appx 1.7 ml, smallbore quadfuse ext set w/4 microclave® clear, 4 check valves, 4 clamps, rotating luer in which it was reported that during 07:30 hr line tracing, the uvc [abbreviation not specified] secondary lumen end was found disconnected in the bed.The disconnection was from the green uvc catheter hub to the extension tubing, proximal to the blue neutron.The infusion had been previously locked from the pump after a medication was last administered at approximately 05:00 hrs.No blood loss was noted on the bed sheets, and no wet fluid was observed.Immediate intervention by the writer was to clamp the line closed, scrub it with chloroprep, and cap the end with a blue neutron.All other connections were checked and traced.The incident involved two pieces of equipment the umbilical catheter and the extension set and it was at this junction that the disconnection had occurred.
Additional Manufacturer Narrative
D9 - date returned to mfr : 5/27/2026.Received one (1) used device for evaluation.The returned device was visually inspected, and the smallbore ext set w/clamp, rotating luer was returned for evaluation.As returned no physical damage or anomalies were visible confirmed.No mating device was returned for evaluation.The male and female luer met the iso design specifications.The reported complaint of separation was not able to be confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" SMALLBORE EXT SET W/CLAMP, ROTATING LUER
• 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: 25154155
• Report Number: 9617594-2026-00449
• Device Sequence Number: 13110716
• Product Code: FMG
• UDI-Device Identifier: 00887709001565
• UDI-Public: (01)00887709001565(17)300601(10)14469999
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: B1415
• Device Lot Number: 14469999
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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
• Patient Sex: Unknown