MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHEC; STOPCOCK, I.V. SET

Catalog Number	MC33687
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one used mc33687 smallbore trifuse extension set w/3 microclaves.As received, the shuntless microclave was stuck down.The microclave was disassembled and a dry spike was found.The reported complaint of a stickdown and subsequent leakage can be confirmed on the mc33687.The probable cause is due to insufficient lubricant applied during assembly in manufacturing.The device history report (dhr) was reviewed and no relevant non conformities were found that would have led to the defect found.
Event or Problem Description
The event involved a 4" (10 cm) appx 0.89 ml, smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luer where the customer reported that the patient was with therapeutic heparin tubing attached to a smallbore trifuse extension which was itself attached to a peripheral intravenous (iv).The peripheral iv site had been previously assessed with tubing followed from syringe to patient.When the patient was settling to bed and stated the following ¿could i have something to keep this iv tubing dry.¿ it was then investigated and felt some moisture on the blood port of the trifuse extension; product was removed and syringe was attached directly to the peripheral iv wherein the iv site was reassessed with saline flush.Upon further inspection, it was discovered that the silicone stopper on the end of the blood port of the trifuse extension was fully depressed and if fluids were pushed into the other "arms" of the extension piece, there was a downward occlusion (the customer placed a cap on the end of the extension to check this) and fluid would leak out of the depressed silicone from the blood port.Additionally, the customer stated that the trifuse was connected to a continuous syringe pump infusing therapeutic heparin when the event occurred.The depressed blood port that was found to be leaking was not connected to any tubing or infusing.It was also mentioned that there was no delay in therapy since it was replaced to continue the infusion.There was patient involvement but no report of harm.

• Brand Name: 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHEC
• 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: 19230673
• Report Number: 9617594-2024-00529
• Device Sequence Number: 5920006
• Product Code: FMG
• UDI-Device Identifier: 00887709064362
• UDI-Public: (01)00887709064362(17)280201(10)13551503
• 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
• Report Date (Section B): 05/02/2024

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: MC33687
• Device Lot Number: 13551503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: PERIPHERAL INTRAVENOUS (IV), MFR UNK; SALINE FLUSH, MFR UNK; SYRINGE, MFR UNK; THERAPEUTIC HEPARIN TUBING, MFR UNK
• Patient Sex: Unknown