MAUDE Adverse Event Report: MITG - KENMEX KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884752505
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports that immediately after opening, they noticed the hole in the tip was clogged therefore catheter insertion was impossible.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
One decontaminated sample with lot number 602681364x was received for evaluation.After performing a visual inspection, an occlusion was observed inside the catheter.The reported condition is confirmed.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.After evaluating the sample it was determined that the occluded tube was caused due to excessive loctite adhesive.The process was reviewed in order to determine possible sections of the process that could result in the reported condition and the investigation concluded that the operator did not follow the standard work instruction during the assembly of the tube and tip to avoid contact of the hole of the weight with the swab to avoid plugging the weight.An improvement for the process is to implement a new fixture dispenser to the operation; this will avoid the excess of adhesive to prevent the problem of the tip occluded inside the catheter and the implementation of the dispenser will help the process by applying a consistency during the dispensing of the loctite adhesive.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): MITG - KENMEX; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• MDR Report Key: 6657965
• Report Number: 9612030-2017-05112
• Device Sequence Number: 11277676
• Product Code: KNT
• UDI-Device Identifier: 10884521519022
• UDI-Public: 10884521519022
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 02/23/2018

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: 01/01/2021
• Device Model Number: 8884752505
• Device Catalogue Number: 8884752505
• Device Lot Number: 602681364X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 06/13/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 10/23/2017; 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1