MAUDE Adverse Event Report: COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: currently unknown, but was noted to have occurred within the last week on (b)(6) 2019. Occupation: director of product discovery. Brand name: device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray this report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray was used during placement of a femoral line. As reported, the wire moved through the needle and the catheter without difficulty. Upon removal of the wire, the wire became stuck in the catheter and the provider had to use force to remove causing the ¿wire stretched and bent at the tip¿. The report indicates no section of the device remains in patient. Additional information regarding the event details has been requested but is currently unavailable. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8445732
• MDR Text Key: 139726801
• Report Number: 1820334-2019-00687
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: C-UDLMY-801J-ABRM-CUSTOM-0049
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial