MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 32 CM (13") EXT SET W/4-WAY STOPCOCK, CHECK VALVE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-H3745

Device Problem Backflow (1064)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

One photo was shared by the customer, which showed fluid through the valve intake of the set.However, no additional leaks, anomalies or incorrect flows are observed on the photo.The complaint of valve malfunction cannot be confirmed based on the photo shared by customer.Lot history review was reviewed and no non conformities were found that would have led the reported condition on the complaint.

Event Description

The event involved a 32 cm (13") ext set w/4-way stopcock, check valve, rotating luer where the customer reported that during patient infusion, they found epirubicin in the route dedicated to premedication with a one-way valve.No physical defects were noted on the device.The customer reported that he patient did not receive the full intended dose; it was a slight loss due to the movement of chemotherapy into the premedication axis.The customer reported that there was no undesirable clinical consequences and nobody was hurt as a consequence of this event.

Manufacturer Narrative

One (1) new sample #011-h3745 was returned for evaluation on 2/16/24.As received no physical damage or anomalies were observed on the sample.The back flow resistances of the check valve was tested as per procedure and no leaks or backflow were confirmed.

• Brand Name: 32 CM (13") EXT SET W/4-WAY STOPCOCK, CHECK VALVE, 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: 18677775
• MDR Text Key: 335216358
• Report Number: 9617594-2024-00130
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3745
• Device Lot Number: 13800567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• 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: EPIRUBICIN, MFR UNK