MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" BIFUSE EXT SET W/2 CHECK VALVES, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1003
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 6" bifuse ext set w/2 check valves, rotating luer where it was reported that iv tubing cracked and broke while attached to the patient.There was no serious harm and no adverse event reported.
Additional Manufacturer Narrative
The device is not available for evaluation: it has been discarded.The investigation is pending.
Additional Manufacturer Narrative
One used bifuse ext set was returned for evaluation.Upon visual inspection, the male luer was observed to be missing from the sample.The reported complaint of a broken set could be confirmed as the sample was observed to be missing its male luer.The probable cause of the broken sample is due to insufficient solvent coverage.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6" BIFUSE EXT SET W/2 CHECK VALVES, 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: 23328479
• Report Number: 9617594-2025-02012
• Device Sequence Number: 18784686
• Product Code: FMG
• UDI-Device Identifier: 00887709000018
• UDI-Public: (01)00887709000018(17)300401(10)14391652
• 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,Followup
• Report Date (Section B): 12/10/2025

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: B1003
• Device Lot Number: 14391652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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