MAUDE Adverse Event Report: COOK INC CAREY-ALZATE-COONS SINGLE LUMEN GASTROJEJUNOSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 510k status: preamendment.(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 that the tip of the carey-alzate-coons single lumen gastrojejunostomy catheter disconnected from the rest of the device, and it could not be put back in place.The doctor was able to perform a temporary fix, the nature of which was not reported; however, the product problem ultimately necessitated the placement of a new jejunostomy catheter.The customer reportedly believed it was a problem with the device.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Additional information: user facility (b)(6) report translation of incident description identified, "during the placement of the probe in interventional radiology, after a slight traction the distal tip has mismatched, impossible to put it back in place.The doctor performed a temporary fixation of the jejunostomy tube.A new intervention had to be programmed to replace a new probe jejunostomy." investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and trends of the device was conducted during the investigation.Clinical assessment: the potential result of tip separation would be surgical removal of the fractured portion of the catheter resulting in ¿significant harm.¿ additional information has been requested.At this time, the clinical assessment cannot eliminate any possible causes for this event such as other device handling, device maintenance, device placement, device failure, or manufacturing related causes.The device was not returned.Therefore, a device evaluation could not be conducted.However, a document based investigation evaluation was performed.Document review shows many protocols in place to identify/prevent this failure mode prior to distribution.Validation review shows proper verifications of the electric torque driver when screwing of the cap/hub assembly.A review of the device history record revealed no nonconformances related to the failure mode.Additionally, a search of the manufacturer's complaint database determined this to be the only event associated with lot number 8114326.The customer states that the tip disconnected during a procedure.Due diligence was conducted in order to find additional information on the type of failure but was unsuccessful.Further investigation into similar complaints has determined this report is most likely due to hub separation of the catheter component (ult10.2-nt-100-p-ns-gjs) provided with this set/tray.A high proportion of the similar complaints was due to procedure error (specifically being removed by patient).This was not reported for this specific complaint and therefore the root cause is unrelated to procedural use.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: CAREY-ALZATE-COONS SINGLE LUMEN GASTROJEJUNOSTOMY SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7318112
• Report Number: 1820334-2018-00601
• Device Sequence Number: 1605440
• Product Code: KNT
• UDI-Device Identifier: 00827002029569
• UDI-Public: (01)00827002029569(17)200818(10)8114326
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: GJS-1020
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/02/2018
• 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