MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; EXD IRRIGATOR, OSTOMY

Catalog Number TDCS-100

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 a patient returned to the hospital due to a chait percutaneous cecostomy catheter trap door being broken.Further clarification determined the chait catheter was leaking and that the trap door was not broken but rather "there seems to be black staining under the door".The customer reported it is unknown when the device was initially implanted and for how long it had been in place before the patient returned to the hospital.The device was removed and replace with a new device without incident.As reported, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Additional information pre-exiting conditions: on (b)(6) 2018, the manufacturer was informed the patient had cystic fibrosis.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.

Event Description

See h10.

Manufacturer Narrative

Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Device evaluation one used device was returned for evaluation.Visual inspection confirmed large amount of biomatter were present on the device.The device would not fully shut when pressed closed, which is likely the source of the leakage.It is likely that the biomatter around the device prevented the device prevented the trapdoor from shutting.Inspection of the used device showed that it was manufactured to specifications.Investigation a document-based investigation reviewed the following: instructions for use, quality control specifications and manufacturing instructions.There is no evidence to suggest the finished product was not made to specifications.The maintenance of the device while in use is outlined in the patient guide.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.Conclusion based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.It is likely that the biomatter around the device prevented the device prevented the trapdoor from shutting which can possibly be attributed to the maintenance of the device or the patient condition.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: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Type of Device: EXD IRRIGATOR, OSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7707342
• MDR Text Key: 114608304
• Report Number: 1820334-2018-02009
• Device Sequence Number: 1
• Product Code: EXD
• Combination Product (y/n): N
• PMA/PMN Number: K982500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: TDCS-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention