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

Model Number G50819

Device Problems Kinked (1339); Unraveled Material (1664)

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

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray this mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that the central line was being placed for heart surgery and the wire kinked.Additional information received from the customer stated that the wire unraveled when it was removed and it could have kinked, but the customer could not confirm.

• Brand Name: Cook Spectrum
• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6896977
• MDR Text Key: 88152335
• Report Number: 1820334-2017-03153
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002508194
• UDI-Public: (01)00827002508194(17)180130(10)5895607
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G50819
• Device Catalogue Number: C-UDLMY-801J-ABRM-HC-FST-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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