MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") APPX 3.1 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO; STOPCOCK, I.V. SET

Catalog Number 011-H1268

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

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.No product samples were received and no photographs or videos were provided for the investigation.Therefore, a comprehensive failure investigation was unable to be performed based on the information that has been provided and a probable cause cannot be identified.A dhr lot# 3687580 and relevant components review were conducted and there were no non conformances found that would have contributed to the reported complaint.

Event Description

The event involved a 4 clave connector infusion set that one of the claves came off when touched resulting in a spill of an unknown chemotherapy medication.It was reported the device was disposed of due to chemotherapy exposure and protocol was followed.There was patient involvement, however there was no reported adverse event or medical intervention.No additional information was received.

• Brand Name: 30 CM (12") APPX 3.1 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO
• 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: patricia sharpe-gregg, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8307014
• MDR Text Key: 137005737
• Report Number: 9617594-2019-00030
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619008291
• UDI-Public: (01)00840619008291(17)230501(10)3687580
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/14/2019

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 Expiration Date: 05/01/2023
• Device Catalogue Number: 011-H1268
• Device Lot Number: 3687580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• 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