MAUDE Adverse Event Report: COOK INC COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Common name: catheter, hemodialysis, non-implanted.Product code: mpb.(b)(6).Pma/510(k) #: k161504.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that there was damage at the red hub of a cook turbo-flo hd hemodialysis catheter.The red hub spun around the catheter making it unable to be secured.The device was removed and replaced.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation.A review of documentation including the complaint history, device history record, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination could not be completed.However, a complaint device was returned for a previous complaint (mfg.Report reference #: (b)(4)) for a similar device and failure mode.The returned device was noted to exhibit a crack and leaked during a functional test.The investigation found that a definitive cause could not be established.Due to the similarities, it is feasible to suggest a similar conclusion between these two complaints.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient controls are in place to detect this failure mode prior to release, and no gaps in production or processing controls were noted.The risks of this device were found to be acceptable when weighed against the benefits.The exact lot number of the complaint device is unknown; however, a review of sales records to the user facility over the past three years narrowed down the lot number of one of four: 7531610, 7550500, 8757365 or 9073246.A review of the device history record for these lots found no relevant nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for these lot numbers.There is no evidence to suggest that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: do not use if the packaging or product has been compromised by physical damage.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned product, and the results of our investigation, a definitive root cause could not be established.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8782526
• MDR Text Key: 150824993
• Report Number: 1820334-2019-01673
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-HDCSYJ-1201J-RSC-IHI-CCT-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention