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

Catalog Number C-RHCS-6.5

Device Problem Occlusion Within Device (1423)

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

Event Date 02/23/2015

Event Type  malfunction  

Event Description

A device was placed in a (b)(6) year old male patient.The catheter became clogged three weeks later.On (b)(6) 2015, the device was removed and replaced with another catheter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

The event is currently under investigation.

Manufacturer Narrative

A review of complaint history, instructions for use (ifu), quality control, and a visual inspection of the returned device was conducted during the investigation.The product was returned in an opened and used condition.A visual inspection noted that the lumen and 29.2cm segment of shaft were observed to be intact.Silicone seal is unbroken between the hub and the snt.Rings and felt were secure and in place.Dark spots within the lumen along the shaft indicate multiple bio occlusions.Attempts to flush the device failed as the catheter was occluded.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an instructions for use, which states warnings, precautions and instructions for use.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

• Brand Name: COOK TPN SINGLE LUMEN CATHETER REPAIR SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr. ; 750 daniels way; p.o. box 489; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4707904
• MDR Text Key: 5646555
• Report Number: 1820334-2015-00167
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002018693
• UDI-Public: (01)00827002018693(17)160401(10)5461711
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Catalogue Number: C-RHCS-6.5
• Device Lot Number: 5461711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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
• Patient Age: 46 YR