MAUDE Adverse Event Report: CARTRIDGE

Device Problem Insufficient Information (3190)

Patient Problems Seizures, Absence (2261); Loss of consciousness (2418)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

The cartridge blood line involved in this incident was discarded and not available for investigation.

• Brand Name: CARTRIDGE
• Manufacturer Contact: ramon ruiz ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 645124212
• MDR Report Key: 4586243
• MDR Text Key: 5339492
• Report Number: 8030638-2015-00002
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1