MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 112" 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 3-PORT NANOCLAVE® MANIFOLD, CHECK; STOPCOCK, I.V. SET

Catalog Number	AM3019
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified (on (b)(6) 2025 used as placeholder) and involved a 112" 15 drop primary set w/2 microclave®, remv 3-port nanoclave® manifold, check valve, rotating luer, 1 ext.The customer reported that the iv tubing, that connects to the extension tubing, when trying to disconnect the tube from the extension that the tubing broke off, and end piece of the tubing remained in the extension tubing.The iv was removed from the patient.There was patient involvement; however, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.The device history review (dhr) was reviewed, and no nonconformities were found that would have led to the reported complaint.Updated information in d9 - device available for evaluation, d9 - date returned to mfg null.

• Brand Name: 112" 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 3-PORT NANOCLAVE® MANIFOLD, CHECK
• 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: 23589174
• Report Number: 9617594-2025-02180
• Device Sequence Number: 9398015
• Product Code: FMG
• UDI-Device Identifier: 00887709088504
• UDI-Public: (01)00887709088504(17)300801(10)14519707
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: AM3019
• Device Lot Number: 14519707
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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