MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number	AC235
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one used ac235 trifuse ext set w/3 microclave for inspection.The male luer was separated from the tubing as received.The tubing and bond pocket were measured and found to meet product dimensions.The reported complaint can be confirmed.The probable cause is due to insufficient solvent applied during manual assembly in manufacturing.
Event or Problem Description
The event occurred on an unknown date involving a 14"(36cm)appx3.0ml, trifuse ext set w/3 microclave clear¿,3 bcv,4-way nanoclave¿ stopcock(red ring) where the reporter stated that they had a failed device event associated with set ext trifuse 14in w/3.The patient was playing on the playmat on the floor.Patient's mom called the rn, and the rn walked in and saw the trifuse extension set was broken off and disconnected for the line.There was patient involvement and no adverse event.

• Brand Name: 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿
• 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: 20834786
• Report Number: 9617594-2024-01716
• Device Sequence Number: 3918169
• Product Code: FMG
• UDI-Device Identifier: 00887709122062
• UDI-Public: 00887709122062
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: AC235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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