MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2a - common device name: additional names: exd irrigator, ostomy d2b - procode: additional product codes: exd.E1 - customer (person): country: aus, postal code: (b)(6), email: (b)(6), phone: (b)(6).E3: clinical nurse consultant.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 or that a death or serious injury occurred; nor is it admission 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

It was reported that a chait percutaneous cecostomy catheter separated.The patient was initially treated on (b)(6) 2023 by the general surgery team.Later, on (b)(6) 2024, the patient presented to the emergency department (ed) with a broken chait catheter.As a result, the patient was put on a waiting list for a catheter replacement procedure.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 or that a death or serious injury occurred; nor is it admission 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

Additional information was provided.It was reported that the patient fell and believes the fall contributed to the separation of the device.

• Brand Name: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18950353
• MDR Text Key: 338251734
• Report Number: 1820334-2024-00392
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K982500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100-L
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• 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