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 Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It has not been received.

Event Description

The event involved a 30 cm (12") appx 3.1 ml, set per infusione, 4 clave® connector, filtro that the customer reported leaking at the level of the clave.The customer stated there was a defective tree when connecting chemotherapy.There was patient involvement, however no report of adverse event.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.No device history review (dhr) was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.

• 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
• MDR Report Key: 9278999
• MDR Text Key: 187703435
• Report Number: 9617594-2019-00378
• 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: 10/16/2019

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 Catalogue Number: 011-H1268
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CHEMOTHERAPY