MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC33332
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 128" (325 cm) appx 9.3 ml, transfer set w/microclave® clear, dual check valve, smallbore bifuse ext set w/microclave® clear (green ring), 0.2 micron filter, rotating luer where the customer reported that the bifuse 0.2 micron filter was found leaking.The set replaced and within 1 hour the bifuse 0.2-micron filter on the new set was found leaking.No excessive pressure was used to prime the set.Set replaced and both sets retained.There was patient involvement and no adverse events reported.This is the first of two events.
Additional Manufacturer Narrative
The device is available for investigation- it has not been received.Additional contact: (b)(6).
Additional Manufacturer Narrative
D9 - date returned to mfg on 12/13/2023.Received one of the two used.List #mc33332, 128" (325 cm) appx 9.3 ml, transfer set w/microclave® clear, dual check valve, smallbore bifuse ext set w/microclave® clear (green ring), 0.2 micron filter, rotating luer; lot #13715949.The inlet filter vents of the used mc33332 transfer sets were confirmed to leak during functional testing.The probable cause of the observed leak is temporary or permanent loss of the hydrophobic properties of the filter vent material due to infusate interaction during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: 18162457
• Report Number: 9617594-2023-00999
• Device Sequence Number: 17768038
• Product Code: FMG
• UDI-Device Identifier: 00887709037816
• UDI-Public: (01)00887709037816(17)280701(10)13715949
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: MC33332
• Device Lot Number: 13715949
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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
• Patient Sex: Unknown