MAUDE Adverse Event Report: COOK INC FREDERICK-MILLER FEEDING TUBE SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2017
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
Customer reported that a patient underwent fluoroscopic placement of a cook frederick-miller feeding tube.Placement was confirmed with barium injection.The device began to leak water when the tube was being rinsed.The tube was removed and another placed during the same procedure.There are no reported adverse patient consequences.The device is not available for evaluation.
Additional Manufacturer Narrative
Additional information: received voluntary medwatch from user facility: (b)(4) to accompany complaint.This was inadvertently not attached to previously submitted mdrs.
Event or Problem Description
Per the user facility voluntary medwatch report, the connection between the white hub and the red syringe port was leaking at the time of the event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, documentation, device history record, specifications of the device was conducted during the investigation.The complaint device was not returned, and so a physical examination could not be performed.A search of the manufacturer's database revealed this to be the only reported complaint associated to the complaint lot number 7551803.The device history record was reviewed and no non-conformances were noted.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the information provided, the actual root cause is unknown and so no conclusion can be drawn.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FREDERICK-MILLER FEEDING TUBE SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6662620
• Report Number: 1820334-2017-01413
• Device Sequence Number: 10777615
• Product Code: KNT
• UDI-Device Identifier: 00827002052765
• UDI-Public: (01)00827002052765(17)191228(10)7551803
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2017

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: C-FMT-8.0-120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 11/15/2017; 12/07/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 12/04/2017; 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1