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; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-H3394

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

The event involved a 30 cm (12") add-on set w/4 check valves, vented cap.It was reported the chemotherapy tree became disassociated when the nurse wanted to place the chemotherapy bag.When she tried to screw the tubing onto the tap on the tree, it came off, which caused a slight leak of the product.The nurse wore gloves with cuffs and an overcoat and was therefore protected against the projection of a few drops.She immediately changed the equipment in question.¿ the status of the product at the time of event is during the installation of the chemotherapy bag.There was no patient involvement, no adverse events/human harm.There was no undesirable clinical consequences and nobody has been hurt.There was a delay in therapy, but this one was completed.The drug administrated was chemotherapy.The leak was cleaned up according to facility protocol.The patient received the full intended dose.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

One (1) used item #011-h3394 connected to a mating device were returned for evaluation.As received one of the adaptor was disconnected from trifurcated connector, both parts were observed through uv light and not enough presence of solvent on the adaptor or trifurcate was confirmed.No damage or excessive force being applied was observed on the sample.Complaint of separation can be confirmed.The probable cause was due to insufficient solvent applied during manual process assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18665187
• MDR Text Key: 335216385
• Report Number: 9617594-2024-00115
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619058050
• UDI-Public: (01)00840619058050(17)280701(10)13706044
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070532
• 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: 03/11/2024

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-H3394
• Device Lot Number: 13706044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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: UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK