MAUDE Adverse Event Report: COOK ENDOSCOPY NASAL JEJUNAL FEEDING TUBE; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	G22301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all nasal jejunal feeding tubes are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an endoscopic procedure, the physician used a cook nasal jejunal feeding tube (njft).A five (5) cm tip fracture [occurred] on exchange over a 260 cm straight amplatz [cook wire guide].[it was] difficult to the pass wire.The wire [went] through the tip, but due to friction, the tip fractured.Additional information was received on 09/18/2017: the tip of the njft detached.The wire guide was only used during exchange for the njft placement.
Additional Manufacturer Narrative
Initially, the following information was provided to cook endoscopy: "during an endoscopic procedure, the physician used a cook nasal jejunal feeding tube.A five (5) cm tip fracture [occurred] on exchange over a 260 cm straight amplatz [cook wire guide].[it was] difficult to the pass wire.The wire [went] through the tip, but due to friction, the tip fractured.Additional information was received on 09/18/2017: the tip of the njft detached.The wire guide was only used during exchange for the njft placement." an initial emdr was submitted on 09/29/2017 based on this information.When the device was received for evaluation, it was identified that the returned device is not a cook njft-10.The adapter on the device suggests it is a medtronic device (purple "kangaroo" adapter).On 11/02/2017, we received the following: the doctor from (b)(6) hospital confirmed that the complaint (dr.(b)(6)) is about the yellow tube that was removed, not a cook device.Based on the device evaluation and the user facility confirming that the device that was returned was the complaint device, this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This correction follow up report is being sent to cancel the initial report submitted relating to this event.

• Brand Name: NASAL JEJUNAL FEEDING TUBE
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6904123
• Report Number: 1037905-2017-00616
• Device Sequence Number: 11091056
• Product Code: KNT
• UDI-Device Identifier: 10827002223018
• UDI-Public: (01)10827002223018(17)190504(10)W3717331
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K043203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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: G22301
• Device Catalogue Number: NJFT-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2017
• Device Age: 8 MO
• Event Location: Outpatient Diagnostic Facility
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR