MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Date 11/20/2013

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

During a pediatric retrospective cohort study comparing antibiotic impregnated and traditional catheters, four spectrum turbo-ject double lumen catheters were placed into pediatric patients with an increased risk of venous catheter related infections.At an unknown time during the study, it was discovered that one patient had developed a catheter related infection.This infection was later classified as candida parapsilosis.

Event Description

During a pediatric retrospective cohort study comparing antibiotic impregnated and traditional catheters, four spectrum turbo-ject double lumen catheters were placed into pediatric patients with an increased risk of venous catheter related infections.At an unknown time during the study, it was discovered that one patient had developed a catheter related infection.This infection was later classified as candida parapsilosis.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Attached files: correction sent to include the original literature source material.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation - evaluation: a review of the instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The instructions for use (ifu) note that prior to insertion, the catheter shaft should not be wiped or immersed in ethyl alcohol, isopropyl alcohol, or other alcohols, acetone or other non-polar solvents.These solvents may remove the antimicrobial from the catheter and reduce the catheter¿s microbial efficacy.A review of the device history record could not be performed as the lot information is unknown.Based on the information provided, no returned product and the results of our investigation, a definitive cause could not be determined.Only one device out of four placed catheters of the same type developed the infection prior to removal, which suggests that it was not a device manufacturing issue.Infection is also a known inherent risk with the product.The most probable cause of this failure was due to unknown effects from patient anatomy.It is possible that the progression of a disease or infection occurred, which was unrelated to the device itself.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.

Event Description

No new event description information to report at this time.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7865602
• MDR Text Key: 119925085
• Report Number: 1820334-2018-02747
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 11/06/2018
• Supplement Dates FDA Received: 09/11/2018; 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other