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

Catalog Number	MC33368
Medical Device Problem Codes	Crack (1135); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.Distributor details: (b)(4).
Event or Problem Description
An event involving a 6" bifuse ext set w/microclave® clear, 2 clamps, rotating luer reported that the patient was receiving tpn through a central line when the mother noticed that the total parenteral nutrition (tpn) had become disconnected from both the central line and the y-connector.The line connector was found to be cracked.Patient needed to be started on dextrose fluids immediately as is tpn dependent.There was patient involvement and unknown harm/adverse event reported.
Additional Manufacturer Narrative
The reported complaint of a disconnection 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.

• Brand Name: 6" BIFUSE EXT SET W/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: 24412225
• Report Number: 9617594-2026-00164
• Device Sequence Number: 20302964
• Product Code: FMG
• UDI-Device Identifier: 00887709038141
• UDI-Public: (01)00887709038141(17)300901(10)14604067
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: MC33368
• Device Lot Number: 14604067
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEXTROSE FLUID, UNK MFR; TPN, UNK MFR
• Patient Sex: Unknown