MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT; STOPCOCK, I.V. SET

Catalog Number B33276

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved a 6" smallbore trifuse ext set w/3 microclave®, 0.2 micron filter, 3 clamps, rotating luer.The reporter stated that total parenteral nutrition (tpn) leaked from the device filter during use/infusion from a peripheral intravenous access point on an infant.The trifuse was infusing tpn, lipids and medication.The patient's linen was saturated and the trifuse was found as 'sticky' to the touch.There was no report of human harm associated with the complaint/event.

Manufacturer Narrative

One used b33276 smallbore trifuse extension set was returned for inspection/complaint investigation.As received, the filter vents on the 0.2 micron filter were wetted out with prior infusate.The extension set was leak tested per product specifications.There was leakage from the filter vents of the 0.2 micron filter.The reported complaint can be confirmed.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT
• 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: 19101606
• MDR Text Key: 340809149
• Report Number: 9617594-2024-00415
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709007192
• UDI-Public: (01)00887709007192(17)280901(10)13766552
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33276
• Device Lot Number: 13766552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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: LIPIDS, MFR UNK.; TPN, MFR UNK.; UNSPECIFIED MEDICATION/INFUSATE, MFR UNK.