MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 144020460

Device Problem No Flow (2991)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved a 60" (152 cm) appx 0.41 ml, smallbore ext set w/clamp, rotating luer where the customer reported an issue of sediment blocking the tubing with the syringe tubing.There is a white precipitate that is forming where the syringe tubing meets the syringe.The medication involved is midazolam mix with normal saline.The normal saline is sourced from a vial of normal saline in the medication room, from kanban cart and a minibag of normal saline.The customer also stated that infusion was connected to a 20ml bd syringe.There is no sediment or clouding occurring in the syringe, only in the tubing.The sediment formed in the same spot, only that spot where the syringe tubing connects to the syringe.There was patient involvement, however, ho harm or medical intervention was reported as a consequence of this event.

Manufacturer Narrative

The device was received 12/13/24 for evaluation.As received a midazolam mix with normal saline solution residuals was observed on the female luer.The set was tested as per procedure and no flow was confirmed just till the fluid path was cleaned.Three photos were shared by the customer, where an unknown white substance on the male luer connector is observed on the three photos, no additional visual anomalies were observed.Complaint of white precipitate solution located where the syringe meets can be confirmed.The probable cause was due an insufate residual that clogged tube during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 60" (152 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18325814
• MDR Text Key: 330959450
• Report Number: 9617594-2023-01156
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709094154
• UDI-Public: (01)00887709094154(17)280701(10)13709698
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 144020460
• Device Lot Number: 13709698
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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
• Treatment: 20ML BD SYRINGE.; MIDAZOLAM, MFR UNK.; NORMAL SALINE, MFR UNK.