MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number A1141

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2024

Event Type  malfunction  

Event Description

It was reported that a 9.5" smallbore trifuse ext set w/3 microclave® clear, nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock generated a leak during patient use.The report stated that the tri-set was found to be leaking at the lumen infusing lipids where the line enters the connection site to the cap.(yellow clamp).The line was replaced and therapy resumed.The patient was receiving total parental nutrition (tpn)/lipids.The patient was unable to obtain tpn/lipids overnight, the patient was required to be transitioned to intravenous (iv) fluids.The patient was being treated for a ventricular septal defect (vsd).There was no patient harm reported.

Manufacturer Narrative

Received one (1) used a1141 trifuse extension set for inspection.No damages or anomalies noted.Received mating devices of one (1) new ams-427.7" minibore ext.Set vygon, one (1) new mc33352, 60" smallbore ext set w/microclave, and one (1) new 10011865, bd extension set smallbore tubing.The a1141 extension set was leak-tested per product specifications.There was a channel leak from the tubing to the bond pocket of the adaptor of the back check valve on one of the trifuse lines.The bond integrity of the channel leak bond was tested.The bond met design specifications.The reported complaint of leakage can be confirmed.The probable cause of the channel leak is due to insufficient solvent coverage applied during manual assembly.The seals of the microclaves and nanoclave were observed.No defects or anomalies.Although no anomalies were observed, the one (1) new 10011865 bd extension set smallbore tubing had a male luer with an inner diameter that would not be compatible with the microclave.The dfu states: "users should confirm mating luers or syringes have an internal diameter range of 0.062¿ to 0.110¿.Check the internal diameter of the male-luer connector of the mating syringe prior to using it to access the clave.Products outside of these dimensional tolerances should not be used.A device history review (dhr) review could not be conducted because no lot number(s) was were identified.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• Type of Device: 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: 18899813
• MDR Text Key: 337767409
• Report Number: 9617594-2024-00262
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: A1141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TPN/LIPIDS, UNK MFR
• Patient Age: 4 MO
• Patient Sex: Female