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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 14"(36cm)appx3.0ml, trifuse ext set w/3 microclave clear¿,3 bcv,4-way nanoclave¿ stopcock(red ring) and occurred on an unspecified date.It was reported that the male adaptor collar appears to have disconnected.This happened while being transferred to bed.Samples are available for return.There was patient involvement, and no injuries or adverse event.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Received one (1) used ac235 trifuse extension set w/3 microclaves for inspection.As received, the male luer was separated from the tubing.Examination of the tubing showed spotty solvent coverage.The reported complaint of the separation can be confirmed.The probable cause is due insufficient solvent coverage during manual assembly in ensenada.

• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19652547
• Report Number: 9617594-2024-00859
• Device Sequence Number: 6623833
• Product Code: FMG
• UDI-Device Identifier: 00887709122062
• UDI-Public: (01)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: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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