MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") APPX 3.2 ML, SET AMBRATO PER INFUSIONE, 4 CLAVE®, PERFORATORE CON FI; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number 011-H1368

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

The event involved a 30 cm (12") appx 3.2 ml, set ambrato per infusion, 4 clave®, perforator con filter where a connector from one of the 4 channels became "unsealed" and fell onto the patient and the nurse, along with the cytotoxic bag ( epirubicin from the lab medac), resulting in the dispersion of cytotoxic substance on the nurse, the patient, the chair, etc.There was patient involvement but no one was harmed, no medical intervention; however, the therapy was unsuccessful.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.

• Brand Name: 30 CM (12") APPX 3.2 ML, SET AMBRATO PER INFUSIONE, 4 CLAVE®, PERFORATORE CON FI
• Type of Device: ADMINISTRATION SETS AND ACCESSORIES
• 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: 17968558
• MDR Text Key: 326376469
• Report Number: 9617594-2023-00860
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619009359
• UDI-Public: (01)00840619009359(17)280201(10)13544640
• 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
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1368
• Device Lot Number: 13544640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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 FROM THE LAB MEDAC