MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	MC3316
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a broken connector 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.
Event or Problem Description
The event involved a 7" (18cm) appx 0.37ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer where it was stated in the report at the start of the shift that there was no health care assistant (hca) on the unit until 1500.Additionally, the unit was down one nurse.They called the patient's mother at 0740 to inform her that there was no hca available to provide 1:1 care.The patient was in a short-sleeved shirt when they took them into their care.Prior to going into another patient's room, they looked at the nursing station to see if any other nurses were available to watch the patient.They came back into the patients' room at 0815 when total parenteral nutrition (tpn) was scheduled to finish.Patients were sitting in the chair and stood up; they noticed blood on the patient's back and on the chair and drips of blood on the floor where the patient had walked.They went into the room and assessed the peripherally inserted central catheter (picc) line which upon assessment was still intact.The iv line running pn had broken at a hub and was running pn on the ground and blood was back flowing out of the picc onto the patient's backside.They immediately clamped the picc line.The picc line was then flushed and heparin locked and noted to work and have no damage to it.There was patient involvement, but no patient harm reported.

• Brand Name: 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS,
• 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: 23328213
• Report Number: 9617594-2025-02010
• Device Sequence Number: 13415859
• Product Code: FMG
• UDI-Device Identifier: 00887709037458
• UDI-Public: (01)00887709037458
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: MC3316
• 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: 09/22/2025
• Initial Report FDA Received Date: 10/17/2025
• 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
• Patient Sex: Unknown