MAUDE Adverse Event Report: COOK INC CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE; DRC TROCAR

Model Number G26867

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that prior to the utilization of the device, upon opening the package, the physician noticed that the catheter access percutaneous entry needle was bent.The device did not come into contact with a patient.

Manufacturer Narrative

A review of the complaint history, device history record, drawings, trends, and quality control of the returned device was conducted during the investigation.The complaint devices were not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished products were not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

Manufacturer Narrative

Additional information received on 22 nov 2017: two catheter access percutaneous entry needles of the same lot (8032860) were reported to be bent.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

• Brand Name: CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7046617
• MDR Text Key: 92786652
• Report Number: 1820334-2017-04008
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00827002268678
• UDI-Public: (01)00827002268678(17)200630(10)8032860
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G26867
• Device Catalogue Number: ADN-18-7.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2018
• Date Device Manufactured: 06/30/2017
• 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