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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Additional/updated information can be found in b3, b5 and e4.Section e additional contact information: (b)(6).Risk manager.
Event or Problem Description
A medwatch mandatory report with uf/importer report # (b)(4) was received on 02-may-2024.
Additional Manufacturer Narrative
The corrected information can be found in h10.

• Brand Name: 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT
• 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: 19101606
• Report Number: 9617594-2024-00415
• Device Sequence Number: 15305667
• Product Code: FMG
• UDI-Device Identifier: 00887709007192
• UDI-Public: (01)00887709007192(17)280901(10)13766552
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2024

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 05/02/2024; 06/06/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/26/2024; 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: LIPIDS, MFR UNK.; TPN, MFR UNK.; UNSPECIFIED MEDICATION/INFUSATE, MFR UNK.
• Patient Sex: Unknown