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	Disconnection (1171); Fluid/Blood Leak (1250)
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
Although the device was requested multiple times to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.If additional information becomes available, supplemental vigilance report(s) will be filed 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 and trifuse devices, in general.For this specific reported event, the patient required two chemotherapies continuously running.The nurse placed the bifuse device to the patient line and attached chemotherapy with an unspecified closed transfer system device (ctsd).The bifuse came off and a small amount of chemo leaked onto floor.The nurse then attached the bifuse to the cstd piece and restarted the chemo.The bifuse came off of the cstd and small amount of chemo again leaked onto floor.The nurse noted that when the bifuse was attached to cstd, it was able to be pulled off of the cstd with only a small amount of pulling, due to the smaller collar on bifuse.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: 22057374
• Report Number: 9617594-2025-01066
• Device Sequence Number: 18219823
• 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: TWO UNSPECIFIED CHEMOTHERAPY DRUGS, MFR UNK; UNSPECIFIED CSTD DEVICE, MFR UNK; UNSPECIFIED PATIENT LINE, MFR UNK
• Patient Sex: Unknown