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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient received a chait percutaneous cecostomy catheter on an unspecified date.The patient reported to the clinical staff that the cap of the device came off four weeks after insertion.The clinical staff reports that it is believed that the patient had pulled the cap off or cut the tube off herself on or about (b)(6) 2017.The chait was previously flushed in the hospital operating room and post op without any complications.The patient reportedly could not access the device and therefore could not empty her bowel.There are no reported adverse patient consequences.The device is not available for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, complaint history, drawing, instructions for use, manufacturing instructions, quality control data, and visual inspection of the returned device were conducted during the investigation.Visual inspection of the returned device was performed.One device was returned with the trap door assembly missing.Biomatter was present on the device.The proximal end of the tubing had a diagonal fracture on it that appeared as if it could have been cut.The fracture was clean and did not appear as if the material was torn.The distal loops were entangled/coiled.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows no conforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The instructions for use provides warnings, including guidance stating to replace the catheter every 6 months as well as precautions for physicians to instruct patients to read and understand the patient guide for caring for their chait percutaneous cecostomy catheter.Based on the provided information,inspection of returned product, and the investigation, the most likely root cause is related to product use or handling.However, a definitive root cause cannot be determined.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.
Event or Problem Description
International customer reported that a patient received a chait percutaneous cecostomy catheter on an unspecified date.The patient reported to the clinical staff that the cap of the device came off four weeks after insertion.The clinical staff reports that it is believed that the patient had pulled the cap off or cut the tube off herself on or about (b)(6) 2017.The chait was previously flushed in the hospital operating room and post op without any complications.The patient reportedly could not access the device and therefore could not empty her bowel.She also reported a "scrapy" sensation.There are no reported adverse patient consequences.The device is not available for evaluation.

• Brand Name: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6662623
• Report Number: 1820334-2017-01601
• Device Sequence Number: 16658901
• Product Code: KNT
• UDI-Device Identifier: 00827002126855
• UDI-Public: (01)00827002126855(17)200210(10)7604122
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K982500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100-L
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1