MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The customer states that while introducing the ng tube into the patient, the tube broke into two pieces in the middle of the tube.The pieces broke outside of the patient.There was no patient injury reported with this event.
Additional Manufacturer Narrative
The dhr file was reviewed indicating that product was released meeting all quality standard requirements.One sample without original package without lot number was received for evaluation.During a visual inspection of the sample received it was observed that the sample does not have a uniform straight cut which is characteristic with cut extruded tubes.The sample shows a jagged cut with a prominent section in the sentinel line which is a characteristic defect caused by tension forces on the extruded tube.The tension forces pull the tube in opposite directions with the extruded tube splitting except for the strongest section corresponding to the sentinel line.The sample received shows signs of having been used with internal residue.In conclusion the most likely root cause is that tension forces were exerted in the middle portion of the tube.Based on the root cause analysis, the reported defect mode was not generated by the manufacturing process therefore no further actions are deemed necessary.The current process is meeting all quality and manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7117328
• Report Number: 9612030-2017-05258
• Device Sequence Number: 11102143
• Product Code: KNT
• UDI-Device Identifier: 20884521067964
• UDI-Public: 20884521067964
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/22/2018

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 Expiration Date: 03/01/2022
• Device Model Number: 461412
• Device Catalogue Number: 461412
• Device Lot Number: 708124664X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO