MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), R; STOPCOCK, I.V. SET

Catalog Number	MC330360
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a 10" quadfuse ext set w/4 microclave® clear, 5 clamps (3 white, 1 blue, 1 red), rotating luer where it was reported a broken quad fuse where the tubing that connects to patient side came out of the luer-lock housing that goes into the patient¿s microclave cap.The broken tubing was found after connected to patient for several hours.Luer lock remained in patient¿s cap keeping cap engaged while quad fuse was detached entirely from patient.Infusing medication while connect to patient.The device leaked and fell off.Multiple meds were infusing.Tacrolimus, ns.There was small blood loss from the patient.No harm was reported.
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where there is missing from the end of the tubing the male luer from the item #mc330360.The item is placed over a withe surface which is looks to be wet.One (1) used sample was returned on 11/21/2023 for evaluation.As received the male luer was observed to be separated and missing from the end of the tubing on the sample.The tube was analyzed through uv light and it was confirmed not presence of solvent on tube.The missing male lues was not returned for evaluation.The tube was measured and it was found within spec.Complaint of separation can be confirmed based on the used physical sample evaluation and the photo shared by customer.The probable cause was due to insufficient solvent applied during manual process assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 10" QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), R
• 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: 18046108
• Report Number: 9617594-2023-00902
• Device Sequence Number: 15328454
• Product Code: FMG
• UDI-Device Identifier: 00887709085299
• UDI-Public: (01)00887709085299(17)271001(10)11003797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/05/2023

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: MC330360
• Device Lot Number: 11003797
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: NORMAL SALINE, MFR UNK.; TACROLIMUS, MFR UNK.
• Patient Sex: Unknown