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

Model Number	N/A
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported the first change of the chait percutaneous cecostomy catheter was on (b)(6) 2018.The chait catheter button kept coming out.The product problem necessitated the exchange of the device on (b)(6) 2018 in the theatre.The device is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaints history, device history records, documentation, drawing, manufacturing instructions, instructions for use, and quality control data 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.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints and will notify appropriate personnel.Per the quality engineering risk assessment no further action is required.

• 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: 7287881
• Report Number: 1820334-2018-00410
• Device Sequence Number: 2117263
• Product Code: KNT
• UDI-Device Identifier: 00827002116320
• UDI-Public: (01)00827002116320(17)200825(10)8171487
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K982500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR