MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR; STOPCOCK, I.V. SET

Catalog Number	MC330027
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D1 - brand name: 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock.D4 and h4 the lot#, expiration date, and manufacture date are unknown.Investigation summary the reported complaint of a tubing break could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a device history record review.
Event or Problem Description
A complaint was received regarding a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock.The reporter stated that in the last week, they had an uptick of incidents in relation to the use of the bi fuse and tri fuse that they use from icu medical.The patient needed to have two continuous chemo running.Rn placed bi fuse on pt line and attached chemo with ctsd.Rn noted that when bifuse attached to cstd it was able to be pulled off of the cstd with small amount of pulling, due to smaller collar on bifuse.Trifuse was then used since collar is longer and able to be fully twisted onto cstd.Patient tubing then got stuck in the recliner as mom (medical mom) was picking patient up.Line snapped on the trifuse in between skinny portion of line and fuse.Again, drops of chemo noted to be on floor but mostly blood due to patient line being open.The product have come in contact with the patient and/or staff member, yet the medication being administered, did not get on patient or staff skin or clothing.The chemo spill cleaned up per facility protocol.Thus, no staff or patient harm reported as a result of the event.

• Brand Name: 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR
• 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: 22097352
• Report Number: 9617594-2025-01112
• Device Sequence Number: 8391892
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: 00887709076419
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 05/28/2025

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: MC330027
• 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: 04/28/2025
• Initial Report FDA Received Date: 05/28/2025
• 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: UNSPECIFIED BIFUSE EXT SET, ICU MEDICAL; UNSPECIFIED CHEMO INFUSATE, MFR UNK
• Patient Sex: Unknown