MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PRESSURE MONITORING SET; DQY CATHETER, PERCUTANEOUS

Model Number G02838

Device Problem Partial Blockage (1065)

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

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

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 needle of the single lumen pressure monitoring set was blocked, and fluid would only flow through it at extremely high pressure.The device did not make patient contact, and no injuries or additional procedures were reported.

• Brand Name: SINGLE LUMEN PRESSURE MONITORING SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• 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: 7589153
• MDR Text Key: 111022587
• Report Number: 1820334-2018-01778
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002028388
• UDI-Public: (01)00827002028388(17)180420(10)5821184
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G02838
• Device Catalogue Number: C-PMS-250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1