MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET

Catalog Number 011-H3393

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

The event involved a 28 cm (11") add-on set w/2 check valves, vented cap, non-dehp where a chemotherapy tubing that was already installed disconnected during infusion in the hematology unit.It was reported that an unspecified cytotoxic drug was used with this device and leaked.The leak was in contact with a patient/healthcare provider.There was patient involvement but no human harm or medical intervention.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.The reported complaint cannot be confirmed based on the information that has been provided.Without the returned device a probable cause is unable to be determined.

• Brand Name: 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14380552
• MDR Text Key: 291972869
• Report Number: 9617594-2022-00127
• Device Sequence Number: 1
• Product Code: FMG
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3393
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 CYTOTOXIC DRUG, MFR UNK