MAUDE Adverse Event Report: COVIDIEN PVC F TUBE 5FRX36IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461008E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reported that the infant was receiving ng tube feeding.Upon assessment, the rn noticed that the crib sheet was wet and there was leaking at the hub of the ng tube.Upon inspection, the ng tube had a cracked at the hub.The device was removed and placed with a new one.There was no patient injury.

Manufacturer Narrative

Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One decontaminated sample was received for the evaluation.After performing visual inspection, the reported condition is confirmed.A gemba walk was performed at the manufacturing area with the multifunctional team (quality, manufacturing, engineering).The reported condition was not found during the manufacturing process, assembly or the shipping area nor any additional process that could generate it.The workstations, tools and fixtures were reviewed to verify if anomalies of conditions may cause the condition reported, no findings were detected.Stress can be observed in the connector and tube assembly indicating that there was additional handling after the manufacturing process that could cause the reported condition.The root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness this time.This is considered an isolated incident.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.A production notification was sent to all personnel to ensure that they are aware on the condition reported by the customer.

• Brand Name: PVC F TUBE 5FRX36IN W ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9889516
• MDR Text Key: 186020458
• Report Number: 9612030-2020-02443
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521547230
• UDI-Public: 10884521547230
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461008E
• Device Catalogue Number: 461008E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2020
• Patient Sequence Number: 1
• Patient Age: 16 DA
• Patient Weight: 2