MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-H3394

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

The event occurred on various days in (b)(6) 2023 and involved a 30 cm (12") add-on set w/4 check valves, vented cap.It was reported one of the branches of the chemo tree was not sealed/welded like the other 3.When changing tubing (unscrewed) because all occupied, it was completely removed.The problem repeated with 2 units.There was no check valve which caused chemotherapy treatment to leak on providers hands and on the floor.The tubing was reinstalled to stop the leak and absorption protocol with decontamination kit was applied.There was patient involvement, however no report of harm.This captures the third of three occurrences.

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The device history review (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP
• 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: 16769400
• MDR Text Key: 313814407
• Report Number: 9617594-2023-00146
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058050
• UDI-Public: (01)00840619058050(17)271001(10)9516933
• 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: Other
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3394
• Device Lot Number: 9516933
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: UNSPECIFIED CHEMOTHERAPY, UNK MFR.