MAUDE Adverse Event Report: COOK INC ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
It was reported during an exchange, the ultrathane carey-alzate-coons gastrojejunostomy replacement catheter was placed and upon pulling the piece in the middle it broke, instead of forming the tulip the tip came off.Reportedly the event occurred outside of the patient, the tube was removed and another device was placed with no harm to the patient.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device was in used condition, with the hub separated.The malecot was able to be locked properly.An inspection of the flared proximal end showed that the flare was uneven.The hub fractured as it was being opened, accordingly, an examination of how the flaring sits on the threading could not be conducted.Additionally, 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 showed 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 examination of the returned product, and the results of our investigation, the root cause was determined to be a manufacturing process error.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
Additional information: the original analysis of the separated flare on this device was a visual inspection.The device was reexamined to perform more objective flare measurements.The device was returned in a used and damaged condition, with the proximal fitting separated from the device.The proximal flare was out of round potentially due to compression forces of the catheter shaft between the proximal fitting cap and adaptor or potentially due to forces experienced during separation of the shaft from the proximal fitting.The minor and major diameters of the returned device flare measure 0.223" and 0.245" respectively.This is securely within manufacturing targeted specification (0.210"-0.281").

• Brand Name: ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6093044
• Report Number: 1820334-2016-01258
• Device Sequence Number: 16550614
• Product Code: KNT
• UDI-Device Identifier: 00827002270442
• UDI-Public: (01)00827002270442(17)190407(10)6873035
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2017

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: ULT10.2-NT-100-P-NS-GJS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided; 11/13/2017
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 05/15/2017; 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1