MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 45" (114 CM) APPX 9.0 ML, EXT SET W/3 GANG 4-WAY STOPCOCKS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number B4141

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

One used device was returned for evaluation.As received no physical damage or anomalies were confirmed on the samples.The device was tested per procedure and there were no leaks from the unions between stopcock and stopcock or along the device.Therefore, probably cause was unable to be determined.A device history review could not be conducted because no lot number(s) was/were identified.

Event Description

The event occurred on an unspecified date and involved a 45" (114 cm) appx 9.0 ml, ext set w/3 gang 4-way stopcocks, rotating luer.The report stated that they were having issues with the product leaking between the manifold ports.The event occurred during patient use in the operating room and they noticed that the patient's blanket was wet.The tubing was not replaced.There was patient involvement and no human harm reported.This is report three of three.

• Brand Name: 45" (114 CM) APPX 9.0 ML, EXT SET W/3 GANG 4-WAY STOPCOCKS, 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: 18307992
• MDR Text Key: 330937523
• Report Number: 9617594-2023-01119
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B4141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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