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	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 14"(36cm)appx3.0ml, trifuse ext set w/3 microclave clear¿,3 bcv,4-way nanoclave¿ stopcock(red ring).The customer reported that the the male connector detached from the end of the tri-fuse device.There was no injury or adverse event associated with this complaint/event.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Two photos were provided by the customer showing the packaging of the device and the male luer separated from the tubing.50 new ac235 trifuse extension sets were received for inspection/investigation.No defects or anomalies noted.Each set was tested for bond integrity per product specifications and were found to have met product performance expectations.The reported complaint can be confirmed from the photo provided.The probable cause is unknown.The complaint was unable to be replicated on the new samples.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 19281520
• Report Number: 9617594-2024-00572
• Device Sequence Number: 18036696
• Product Code: FMG
• UDI-Device Identifier: 00887709122062
• UDI-Public: (01)00887709122062(17)290201(10)13893753
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 13893753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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