MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 16.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 2 GANG 4-W; STOPCOCK, I.V. SET

Catalog Number B90019

Device Problem Material Separation (1562)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.

Event Description

It was reported that, on an unknown date, a 128" (325 cm) appx 16.6 ml, 15 drop primary set w/2 microclave¿, remv 2 gang 4-way clave¿ stopcock, rotating luer, 2 fell during use on a patient.The report stated that the intravenous (iv) tubing fell apart at a connection immediately after a luer lock in line.There was no patient harm reported.

Manufacturer Narrative

The reported complaint of tubing falling apart could be confirmed based on the image provided by the customer.No product samples, or videos were returned for investigation.However, an image was provided by the customer showing the area of the defect.A failure mode was not able to be identified with the image provided by the customer.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.Without the return of the reported sample, a probable cause could not be confirmed.

• Brand Name: 128" (325 CM) APPX 16.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 2 GANG 4-W
• 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: 18655732
• MDR Text Key: 334733826
• Report Number: 9617594-2024-00107
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B90019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• 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