MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint involved the following device: 9.5" smallbore trifuse ext set w/3 microclave® clear,nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock.The blood port of the device reportedly broke while attempting to flush for a patient.The rn went to the patient room to administer medication of iv zofran.The rn took off the green hub cap off of the blood port, cleaned per policy with prevantix, and attached a saline flush.As the flush was attached, a loud popping sound was heard with small plastic fragments and iv fluids spilling onto bed.The piv (peripheral venous line) began to "backflow blood towards no open site of tubing".There was no patient harm.
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Additional Manufacturer Narrative
The reported complaint of a broken blood port could not be confirmed.Without the return of the sample or a photo/video a comprehensive review could not be performed and a probable root cause could not be determined.No lot received for a device history record (dhr) review.Updated information can be found in d9.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• 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: 23407995
• Report Number: 9617594-2025-02070
• Device Sequence Number: 21055476
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: 00887709069343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: A1141
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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: PIV (PERIPHERAL VENOUS LINE), MFR UNK.; PREVANTIX, MFR UNK.; SALINE SOLUTION, MFR UNK.; UNSPECIFIED FLUIDS, MFR UNK.; ZOFRAN, MFR UNK.
• Patient Sex: Unknown