MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3; STOPCOCK, I.V. SET

Catalog Number	MC33688
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where the top of the microclave is observed to be broken, and a section of the seal is shown.One (1) used list# mc33688, 4" connected to a used, trifuse ext set were returned for evaluation.As received the one of the claves was observed to be broken.The missing piece was not returned for evaluation, however a breach marks on the broken section was confirmed.No additional damage or anomalies were observed.The broken microclave was dissembled and an unknown dry solution outside the body and a parting coring on the seal was confirmed.A crack outside other 2 microclaves was observed.Complaint of one of the claves found to be broken can be confirmed.The probable cause of the partial coring is due to an incompatible mating device during use, this led to an outside leak on the microclave, causing degradation of material coming the lipids in contact with the plastic, facilitating the break due to an unintentional twisting force during use.Lot history review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
The event involved a 4" smallbore quadfuse ext set w/4 microclave® clear, 3 check valves, 4 clamps (3 white, red), rotating luer where the customer reported that during bed bath, clave of one of patient's medications found to be broken and draining into the bed.There was patient involvement, however, harm was not reported as a consequence of this event.

• Brand Name: 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3
• 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: 21698175
• Report Number: 9617594-2025-00556
• Device Sequence Number: 18496726
• Product Code: FMG
• UDI-Device Identifier: 00887709064379
• UDI-Public: 00887709064379
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: MC33688
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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