MAUDE Adverse Event Report: COVIDIEN GSTRO FEED TBE W/Y PRT 12FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884715122

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem Skin Irritation (2076)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but to date has not been received.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reports the g-tube was inserted on (b)(6) 2019, they noticed the tube was blocked and leaking from the port.The patient developed irritation and red skin from the leakage.

Manufacturer Narrative

The device history record (dhr) file was reviewed and no discrepancy was found for the reported condition.Based on the complaint information provided by the customer the sample received was used for a period of 31 days; this continued use results in a degradation of the tubing quality.The device¿s instructions for use (ifu) included within the packaged product states in section 5: ¿replace tube at four (4) week intervals to ensure optimum tube patency.¿ the use of the tube for periods longer than 4 weeks can result in adverse negative effects with possible factors that affect product performance including over-inflation, the liquid used to inflate the balloon of the device, and tube maintenance.In summary the root cause for the reported condition is prolonged continuous use that exceeds the recommended 4-week period.The product was released meeting all quality performance requirements; as stated in the complaint information, the sample performed according to product specification for a period of 31 days which exceeds the recommended change period of 4 weeks.A review of the current process was executed locating no sections that could result in adverse effects for product performance.The process will continue to be monitored in order to resolve any negative impacts on product and/or process performance.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8401195
• MDR Text Key: 138279732
• Report Number: 9612030-2019-02114
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884715122
• Device Catalogue Number: 8884715122
• Device Lot Number: 1809515364
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 23