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

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
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
The customer reported that the protruding portion of the device which secures the trapdoor was missing.It was confirmed that the catheter had to be removed and replaced, but the product issue was reportedly noticed upon the initial placement of the device.No adverse effects or other complications were reported.The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawings, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was completed during this investigation.The device history record for lot and component lot number were reviewed.No related non-conformances were identified.A search of our complaint records indicates that this is the only complaint for this lot number.The product was returned.One opened, used chait pediatric cecostomy catheter was returned.The trap-door fitting was found to not have a plug component.However, due to device use and opened packaging, we cannot confirm that the device was not manufactured to current specifications.Based on the provided information, inspection of returned product, and the investigation results, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is required at this time.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6959177
• Report Number: 1820334-2017-03581
• Device Sequence Number: 19003601
• Product Code: KNT
• UDI-Device Identifier: 00827002363922
• UDI-Public: (01)00827002363922(17)200707(10)7999258
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K982500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100-M
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1