MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC33315
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
Event or Problem Description
The complaint/event involved a 5" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer.The customer reported that they had an uptick of incidents with the bifuse device, in general.For this specific reported event, the patient was connected to a central venous line (cvl) with iv fluids (ivf) using a syringe (medline) on the bifuse.The nurse was called to room for a tubing break at the bifuse connection.The patient did not do anything specific per mom (medical mom) for tubing to have broken like it did.It was also stated that unspecified chemo was hooked up to the connector and no chemo was lost.Although the product could 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, there was no staff or patient harm reported as a result of the event.

• Brand Name: 5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER
• 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: 22057066
• Report Number: 9617594-2025-01063
• Device Sequence Number: 19876625
• Product Code: FMG
• UDI-Device Identifier: 00887709037694
• UDI-Public: 00887709037694
• 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): 05/20/2025

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: MC33315
• 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: 04/25/2025
• Initial Report FDA Received Date: 05/20/2025
• 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: IV FLUIDS (IVF), MFR UNK.; UNSPECIFIED CENTRAL VENOUS LINE (CVL), MFR UNK.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.; UNSPECIFIED SYRINGE, MFR MEDLINE.
• Patient Sex: Unknown