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

Device Problem Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Additional contact e1: (b)(6).

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 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
• Type of Device: 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
• MDR Text Key: 317867624
• Report Number: 9617594-2023-00237
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: (01)00887709037267(17)271201(10)13477720
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1