MAUDE Adverse Event Report: COOK INC LOCK PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Catalog Number C-PCS-830-LOCK

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 while using a lock pericardiocentesis catheter set a piece broke off the device and the drainage had to be removed completely from the body; it was further noted that the distal weld connection separated from the coil which allowed the coil to elongate.There were no other adverse effects to the patient reported.Additional information had been requested but not provided by the reporter.

• Brand Name: LOCK PERICARDIOCENTESIS CATHETER SET
• Type of Device: GBX CATHETER, IRRIGATION
• 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: 7374418
• MDR Text Key: 103613932
• Report Number: 1820334-2018-00855
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002024335
• UDI-Public: (01)00827002024335(17)180710(10)6025092
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-PCS-830-LOCK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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
• Patient Outcome(s): Required Intervention