MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA INTRATHECAL CATHETER KIT; IMPLANTABLE INTRATHECAL CATHETER KIT

Model Number 11823

Device Problem Defective Device (2588)

Patient Problem Pain (1994)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient went to the emergency room for increased pain.A catheter access port (cap) dye study was performed by the patient's pain management physician and the catheter was observed to be occluded.The catheter was subsequently replaced.

Manufacturer Narrative

Internal complaint number: (b)(4).Additional information was received on 9/5/2018 concerning the catheter.

Event Description

A health care professional reported that the patient was taken to the operating room and the catheter was checked and confirmed to be patent.The catheter was therefore not replaced.

• Brand Name: PROMETRA INTRATHECAL CATHETER KIT
• Type of Device: IMPLANTABLE INTRATHECAL CATHETER KIT
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer Contact: karen matis ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 7832595
• MDR Text Key: 118754327
• Report Number: 3010079947-2018-00175
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: 0100810335020099171812101022565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2018
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 22565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2016
• 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
• Patient Outcome(s): Required Intervention