MAUDE Adverse Event Report: COOK, INC. SINGLE LUMEN CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Catalog Number C-PUM-3014J-18-20.0

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 04/11/2014

Event Type  Injury  

Event Description

Picc line may have migrated while it was inside the male pt.The customer is not sure if the line was the cause of the problem, (as sometimes the line can migrate, meaning it move out of the svc) fluid had entered the chest area, they used drains to remove the fluid.The picc line was also removed.No additional information was provided by the reporter.

Manufacturer Narrative

Unk as not provided by reporter.(b)(4).

• Brand Name: SINGLE LUMEN CENTRAL VENOUS CATHETER SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 3802999
• MDR Text Key: 4384663
• Report Number: 1820334-2014-00211
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: C-PUM-3014J-18-20.0
• Device Lot Number: 4104411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2014
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2013
• 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