MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN HEPARIN COATED CENTRAL VENOUS CATHETER TRAY

Catalog Number C-UTLM-501J-25-6.5-WCE-BH

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

The micropuncture wires were sticking on the needle after insertion.The wire was fed through and when the doctor tried to remove the needle, it became stuck on the wire so the needle and wire had to be removed completely.The physician then attempted on the other side himself and the same thing happened, so on both occasions the needle had to be removed with the wire in it.The patient did require an additional procedures due to this occurrence; as no central access was possible the pediatric patient had to have an intraosseous needle inserted to administer fluid and drugs.This was successful and the patient recovered.

• Brand Name: TRIPLE LUMEN HEPARIN COATED CENTRAL VENOUS CATHETER TRAY
• 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: 6894896
• MDR Text Key: 87445506
• Report Number: 1820334-2017-03341
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002506985
• UDI-Public: (01)00827002506985(17)151215(10)5483408
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-UTLM-501J-25-6.5-WCE-BH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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