MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 UNITS OF EXT SET TUBING PUR YELLOW WITH SPIKE, Y-CLAVE, CLAMP, LUER CHECK VAL; STOPCOCK, I.V. SET

Catalog Number 011-H2394

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review could not be completed due to the unknown lot number.

Event Description

The event involved a 5 units of ext set tubing pur yellow with spike, y-clave®, clamp, luer check valve that when the tubing inserted in the chemo vial was pierced there was presence of the droplets in the bag.There was a leak noted at the level of the tubing, at the base of the spike.The nurse on duty was called as the chemo vial supposed to be injected in the morning would be delayed, since it had to be prepared again.The patient was not connected to the device during the event, and there were no negative clinical consequences for a patient and operator.

Manufacturer Narrative

A series of photographs were provided and evaluated.The photos show one 011-h2394 extension set.The tubing between the bag spike and the y-clave appears to be torn.A device history review could not be conducted because no lot number(s) was/were identified.The reported complaint of damage tubing and subsequent leakage can be confirmed based on the images provided.However, without the return of the sample a probable cause cannot be identified.

• Brand Name: 5 UNITS OF EXT SET TUBING PUR YELLOW WITH SPIKE, Y-CLAVE, CLAMP, LUER CHECK VAL
• 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
• MDR Report Key: 10804799
• MDR Text Key: 219553500
• Report Number: 9617594-2020-00480
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2394
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC CHEMO VIAL, MFR UNK