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 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event 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.

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.

Manufacturer Narrative

Additional information in a2, b3, b5, e1, e3, and g2.

Event 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.

• 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: 19086485
• MDR Text Key: 340685409
• Report Number: 9617594-2024-00400
• 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,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2024

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: 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
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 10/09/2015
• Supplement Dates FDA Received: 05/07/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• 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, UNK MFR; PERIPHERAL IV, UNK MFR; TOTAL PARENTERAL NUTRITION, UNK MFR
• Patient Age: 4 DA