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
Additional Manufacturer Narrative
Additional information in a2, b3, b5, e1, e3, and g2.
Event or Problem Description
Additional information was provided by the customer: medwatch mandatory report with uf/importer report # (b)(4) on 02-may-2024.It was stated in the report that it was a product problem.The date of the event was on 12-mar-2024 and the date of the report is on 00-apr-2024.The product was not a single-use device that was reprocessed and reused on a patient.The initial reporter was pamela harding, a health professional - risk manager.The report was sent to the manufacturer on 00-may-2024.
Additional Manufacturer Narrative
Received one used b33276 smallbore trifuse extension set for inspection.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
Correction: related report number added to h10 versus in b5 from previous supplemental report.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The 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 where it was reported that the device leaked.The reporter stated an infant had a peripheral iv with trifuse was receiving total parenteral nutrition (tpn) and lipids, with a saline locked medication line when it was noted that the infant's linen was saturated and the tpn filter was sticky.The nurse observed that the fluid was leaking from the tpn filter.There was patient involvement, however, no harm was reported.

• 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: 19086485
• Report Number: 9617594-2024-00400
• Device Sequence Number: 7099897
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/14/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 05/02/2024; 06/06/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/07/2024; 05/30/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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, UNK MFR; PERIPHERAL IV, UNK MFR; TOTAL PARENTERAL NUTRITION, UNK MFR
• Patient Age: 4 DA
• Patient Sex: Unknown