MAUDE Adverse Event Report: COOK INC COOK AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Contamination (1120)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, or unavailable.Phone: (b)(6).Occupation: unknown.Pma/510(k) #: exempt.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 while using a cook airway exchange catheter during a tube exchange, plastic parts were found inside the catheter during flushing.The product was not inspected prior to use, as it is a daily use product.Additional information has been requested regarding event details and patient demographics, but is not available at the time of this report.

Event Description

It was reported in additional information received on 31mar2019 that the particles were noticed after the exchange procedure was completed and that the particles were found to be stuck on the device.The device was returned for evaluation on 02apr2019, and it was found during preliminary analysis that the catheter and balloon were split in addition to red particles that were noted upon visual examination.The back end was slightly flared, indicating a fitting should be present.It was also noted during the investigation that the device returned was not a cook device.A request to return the correct device was made to the customer.It was later reported on 10apr2019 that the device involved in the incident was not a cook product.A device from another manufacturer was returned by the customer in cook outer packaging by mistake.The device will be returned to the customer.Therefore, this event is not reportable under fda 21 cfr part 803 as the reported device is not manufactured or marketed by cook.

Manufacturer Narrative

Additional information: event and concomitant medical products.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 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 AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8448382
• MDR Text Key: 139711650
• Report Number: 1820334-2019-00753
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002058804
• UDI-Public: (01)00827002058804(17)200517(10)7920952
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-19.0-83
• Device Lot Number: 7920952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 03/31/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1