MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.53 ML, SMALLBORE TRIFUSE EXT SET W/2 MICROCLAVE¿, 3 CLAMPS, RO; STOPCOCK, I.V. SET

Catalog Number	B33709
Medical Device Problem Codes	Backflow (1064); Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo was reviewed showing the affected sample and it was observed to have blood residuals on the sample.The reported complaint of a leak could be confirmed from the photo provided.However, without the return of the used sample a comprehensive review cannot be performed, and the probable cause is unknown.A device history review could not be completed due to the unknown lot number.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a smallbore trifuse ext set and it was reported that blood was back flowing from double lumen central venous catheter (dl cvc) (red cap) trifuse.One extension of the trifuse had cracked so blood was back flowing and leaking on the ground.Registered nurse clamped red line, paused pca (patient-controlled analgesia), narcan and carrier, exchanged trifuse and restarted fluids/meds.This was discovered while prepping/priming the tubing.There was patient involvement, and no harm.

• Brand Name: 6" (15 CM) APPX 0.53 ML, SMALLBORE TRIFUSE EXT SET W/2 MICROCLAVE¿, 3 CLAMPS, RO
• 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: 24386504
• Report Number: 9617594-2026-00159
• Device Sequence Number: 21392430
• Product Code: FMG
• UDI-Device Identifier: 00887709077393
• UDI-Public: 00887709077393
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: B33709
• 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: 02/04/2026
• Initial Report FDA Received Date: 02/19/2026
• 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: NARCAN, UNK MFR.; PCA PUMP, UNK MFR.; UNSPECIFIED RED LINE, UNK MFR.
• Patient Sex: Unknown