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 Fluid/Blood Leak (1250)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, it has not been received.

Event Description

The event involved a 32 cm (13") ext set w/4-way stopcock, check valve, rotating luer where it was reported that during chemotherapy infusion, a leakage occurred of pertuzumab at the level of the extension.Upon review, it appears to be bent at the end.There was no harm reported.

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The device history review 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.The device history review for lot 13528042 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

Manufacturer Narrative

A used 011-h3745 ext set w/4-way stopcock, check valve, rotating luer wasr returned for the investigation.It was confirmed with the check valve being misassembled at the bond to the stopcock and not being fully engaged.This type of misassembly during bonding will result in leakage during use.The probable cause is an assembly error during manual bonding at the manufacturing site.Additional information d9- sample received for investigation on 8/29/2023.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17145423
• MDR Text Key: 318052758
• Report Number: 9617594-2023-00248
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619027117
• UDI-Public: (01)00840619027117(17)280101(10)13528042
• 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,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 13528042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 08/14/2023; 09/25/2023
• Supplement Dates FDA Received: 08/14/2023; 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: PERTUZUMAB, MFR UNK