MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number	A1141
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	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A series of photos were shared by the customer, where a section of the y-clave is observed to be broken from set #a1141, no additional damage besides the mentioned is observed on the photos.One (1) used.List #a1141, 9.5" connected to, 0.9% sodium chloride injection, usp 10 ml bd syringe was returned for evaluation.As received some residuals were inside the sample and the nano clave was observed to be broken from y-connector.The broken section was visually inspected and a stress within was observed.Complaints of separation can be confirmed, on one side of the plastic the deformation shows stress whiting and on the other beach marks.The probable cause based on this is typically due to unintentional bending force applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
It was reported that a smallbore trifuse set, 3 microclave clear was found to break and cause a leak during patient use.The report stated, "quadset snapped off of piv while drawing labs, causing blood to flow on to patient/bed." the packaging was not saved.This is a single-use device that was not reprocessed nor reused on a patient.Sample photos are provided showing the defective device.The device involved in this event is not available in the facility.No other devices were being used on the patient at the time of the event that may have caused or contributed to the event.There was no patient harm reported.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• 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: 20467776
• Report Number: 9617594-2024-01460
• Device Sequence Number: 15265286
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343(17)290401(10)13993021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 10/16/2024

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: A1141
• Device Lot Number: 13993021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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 Age: 13 YR
• Patient Sex: Female