MAUDE Adverse Event Report: COVIDIEN ARG EDLICH GAST LAV TRY LRG 11.2MM; GASTRO INTESTINAL TUBE

Model Number	8888750018
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 03/13/2017.An investigation is currently under way.Upon completion the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gastro intestinal tube.The customer reported that upon opening the package the tubing was badly kinked.It was to the point where it could not be used.This is the third occurrence in the same item/different lot numbers that this customer has encountered.
Additional Manufacturer Narrative
Submit date: 3/13/2017.The report refers to product code 8888750018 arg edlich gast lav try lrg 11.2mm with lot number 162460006.The device history record review of the reported lot number, shows evidence that the product was released according to all established procedures and qa documentation.Three samples were received and a visual test was performed.The reported condition was confirmed; the tubing presents a kink.The possible root cause could be related to the packaging process if the operator took the tube and did not properly place it within the individual package causing the reported condition.No corrective actions will apply as there is no trending related to the issue reported, however a quality alert was generated to notify manufacturing personnel about this situation.This complaint will be used for tracking and trending purposes.

• Brand Name: ARG EDLICH GAST LAV TRY LRG 11.2MM
• Common Device Name: GASTRO INTESTINAL TUBE
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• MDR Report Key: 6401088
• Report Number: 1282497-2017-00255
• Device Sequence Number: 13589089
• Product Code: KNT
• UDI-Device Identifier: 10884521000711
• UDI-Public: 011088452100071110162460006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

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: Other
• Device Model Number: 8888750018
• Device Catalogue Number: 8888750018
• Device Lot Number: 162460006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 03/13/2017
• Patient Sequence Number: 1