MAUDE Adverse Event Report: COVIDIEN 18FR GASTRO FEED TUBE WITH Y PORT X5; GASTRO FEEDING TUBE

Model Number 8884720189

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Occlusion (1984); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

Submit date: 7/13/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 07/06/2016 that an adverse event occurred with a gastro feeding tube.The customer reports that intraduodenal migration of the small balloon was noticed because the flange was too mobile.Consequences to the patient: occlusions, vomiting, scanner, hospitalization.The device was used for 2 months.The device was removed and replaced.

Manufacturer Narrative

The device history record (dhr) file was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.Due to the sample not being provided by the customer, the sample evaluation could not be conducted and the issue reported by the customer could not be confirmed.The most likely root cause indicates that the failure mode could occur due to not following precaution instructions.The device was used for 2 months according to the customer report.The kangaroo gastrostomy feeding tube with y-port is made of medical-grade silicone and it is recommended to replace the tube at four week intervals to ensure optimum tube patency.The process is running according to product specifications meeting quality acceptance criteria.The production personnel were notified about the reported condition.Based on the information available, a corrective action is not deemed necessary at this time.We will keep monitoring the process for any adverse trends that require immediate attention.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 18FR GASTRO FEED TUBE WITH Y PORT X5
• Type of Device: GASTRO FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no.; 125 cuidad industrtrial; tijuana 22500 ; MX 22500
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5790746
• MDR Text Key: 49429267
• Report Number: 9612030-2016-00323
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8884720189
• Device Catalogue Number: 8884720189
• Device Lot Number: 525302264X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization