MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Model Number	MC3302
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The incident involved a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, rotating luer.It was reported there was a brown like particle in the tubing.There was no unexpected or prolonged care happened.The problem happened for the first time and invasive procedure is not provided or not applicable.Defect-detected before use type of incident.There was no patient involvement.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Additional contact e1: (b)(6).
Additional Manufacturer Narrative
Received one (1) new.List #mc3302, 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave¿ clear, clamp, rotating luer; lot #4558747.Received a photo showing the particulate on the packaging.No other anomalies can be observed.The complaint of particulates inside the tubing could not be confirmed.However, the particulate was confirmed to be adhered to the outside of the packaging.As received there was a light brown sticky particulate adhered to the outside of the packaging.No damage or anomalies on the received smallbore ext set nor to the actual sealed package can be observed.No particulates inside device or packaging.How, when, or where the particulate adhered to the outside of the package cannot be determined.The correct lot number was provided (4558747) and the lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.( product returned on 6/16/2023).
Event or Problem Description
Additional information was provided and stated the correct lot number was for 4558747.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17129514
• Report Number: 9617594-2023-00237
• Device Sequence Number: 15067224
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: (01)00887709037267(17)271201(10)13477720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2023

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 Expiration Date: 01/01/2025
• Device Model Number: MC3302
• Device Catalogue Number: MC3302
• Device Lot Number: 4558747
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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