MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, Y-CONNECTOR, ROTATING L; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number CL3950

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Device has been received, but evaluation is not yet complete.

Event Description

The event involved an 8" (20 cm) ext set w/microclave® clear, chemolock¿ port, y-connector, rotating luer where an epirubicin leaked from device after administration, exposing both patient and staff to unnecessary cytotoxic agent that remained inside the device.The patient was exposed to the drug on her bare skin and likely inhaled some chemo particles.The healthcare providers were wearing procedural masks upon discovering the hazardous spill, so may have inhaled some chemo particles.The leak occurred distal to the pump, blue clave cap region, and there was no filter indicated for this protocol.The set up was: regular non-deph iv tubing set, then cl3950, then a y-set extension directly to patient¿s iv cathlon.There was no hole, cut, tears or any defect noted.There was patient involvement but no patient harm.This is the first of three reports.

Manufacturer Narrative

Received one used cl3950 ext set.No anomalies were observed upon visual inspection.The set was tested per product specifications.A channel leak was found at the chemolock bond interface.The bond failed functional testing.The dimensions were found to be within design specifications.The complaint of a leak at the bond interface of the chemolock and y connector can be confirmed.The probable cause of the leakage is inadequate luer insertion due to an error during the manual assembly process.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" (20 CM) EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, Y-CONNECTOR, ROTATING L
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 14213359
• MDR Text Key: 290109377
• Report Number: 9617594-2022-00097
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00887709081338
• UDI-Public: (01)00887709081338(17)250501(10)4808083
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL3950
• Device Lot Number: 4808083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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; IV CATHLON, MFR UNK; NON-DEPH IV TUBING SET, MFR UNK; Y-SET EXTENSION, MFR UNK
• Patient Sex: Female