MAUDE Adverse Event Report: COOK INC MCLEAN-RING ULTRATHANE ENTERAL FEEDING TUBE SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).510k status: not exempt pre amendment.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
During evaluation of a returned mclean-ring ultrathane enteral feeding tube set, it was noted that the catheter's tip was missing.The tip was not returned; however, as of the date of this report, the investigation and evaluation are ongoing.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Device failure analysis was conducted and identified the tip to be missing.With the missing tip, measuring the proper catheter length is not possible and therefore we cannot confirm whether the device is conforming or not.Further inspection of separation location, it was identified that the edge/face is very smooth and not jagged.This gives evidence that he tip was intentionally cut by the customer prior to procedure.Document review shows many procedures in place that should have identified/prevented the failure mode from being distributed.Therefore the root cause is most likely product use/handling and not manufacturing.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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.H3 other text : a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Device failure analysis was conducted and identified the tip to be missing.With the missing tip, measuring the proper catheter length is not possible and therefore we cannot confirm whether the device is conforming or not.Further inspection of separation location, it was identified that the edge/face is very smooth and not jagged.This gives evidence that he tip was intentionally cut by the customer prior to procedure.Document review shows many procedures in place that should have identified/prevented the failure mode from being distributed.Therefore the root cause is most likely product use/handling and not manufacturing.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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: MCLEAN-RING ULTRATHANE ENTERAL FEEDING TUBE SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7417001
• Report Number: 1820334-2018-00933
• Device Sequence Number: 1637417
• Product Code: KNT
• UDI-Device Identifier: 00827002026476
• UDI-Public: (01)00827002026476(17)201023(10)8255769
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MRT-9.5-130
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1