MAUDE Adverse Event Report: COOK INC TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
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
International customer reported that a tiger 2 self-advancing naso jejunal feeding tube was blocked.The clinical staff was not able to provide feeding through the tube.The staff attempted to unblock the device without success.The feeding tube was removed and replaced.No further event information was provided.It is not known if the device is available for evaluation.
Additional Manufacturer Narrative
Additional information: a nasogastric tube had to be immediately inserted since the patient is diabetic, followed by another tiger 2 self-advancing naso jejunal feeding tube.The device has been returned and evaluated.(b)(4).Investigation summary: a review of the complaint history, device history record, specifications, and quality control was conducted during the investigation.A document-based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the failure mode of this complaint.It should be noted there were no other reported complaints for this lot number.One device was returned for investigation.The device was found to be occluded 2.5 cm from the 4th side port.The catheter was dissected and the catheter was noted to be completely occluded with dried blood.The root cause was blood had settled and dried within the catheter, causing an occlusion.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6629240
• Report Number: 1820334-2017-01401
• Device Sequence Number: 11033263
• Product Code: KNT
• UDI-Device Identifier: 00827002504158
• UDI-Public: (01)00827002504158(17)200213(10)7670904
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K043203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: C-NJFT-14-U
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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
• Patient Weight: 67