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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Common device name: additional names: exd irrigator, ostomy.Procode: additional product codes: exd.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 migrated.The device was placed in the patient on (b)(6) 2020.Later, on (b)(6) 2020, the patient pulled the device partially out of the body.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation on (b)(6) 2023, childrens hospital med.Ctr.(united states) reported that a chait percutaneous cecostomy catheter of an unknown rpn from an unknown lot migrated.The device was placed in the patient on (b)(6) 2020.Later, on (b)(6) 2020, the patient pulled the device partially out of the body.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, instructions for use (ifu), and quality control procedures of the complaint device were 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.A review of the device master record (dmr) identified process steps to ensure that nonconforming product does not leave the house.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The ifu, t_tdcs_rev7, packaged with the device contains the following in relation to the reported failure mode: in the precautions section it states: instruct patient to read and understand the patient guide titled ¿caring for your temporary & chait trapdoor cecostomy catheters¿ prior to initial catheter introduction.In the patient instructions for maintenance of chait trapdoor cecostomy catheter section it states: note: instruct patient to read and understand the patient guide titled ¿caring for your temporary & chait trapdoor cecostomy catheter¿ prior to initial catheter introduction.Based on the information provided, no product returned, and the results of the investigation, the cause of this event was determined to be unintended user error.There is labeling instructing proper care of the chait device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 16708872
• MDR Text Key: 312986897
• Report Number: 1820334-2023-00392
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 4 YR
• Patient Sex: Male
• Patient Weight: 28 KG