MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL2100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event occurred on an unspecified date and involved a chemolock port that experienced a chemo leak due to the chemolock attached.No additional information was provided.

Manufacturer Narrative

Initially it was reported the device would be returned for evaluation.There were no product samples, videos, or photographs returned for investigation.A device history review (dhr) was not conducted as no lot number was identified.A probable cause cannot be identified based on the information that has been provided.Additional information can be found in sections concomitant medical products and mfr site.

• Brand Name: CHEMOLOCK¿ PORT
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 8433834
• MDR Text Key: 139241976
• Report Number: 9617594-2019-00079
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL2100
• Device Catalogue Number: CL2100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSP CHEMOLOCK; UNSP CHEMOLOCK