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

Model Number	461008E
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2020-02443
• Device Sequence Number: 2101764
• Product Code: PIF
• UDI-Device Identifier: 10884521547230
• UDI-Public: 10884521547230
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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: No Information
• Device Model Number: 461008E
• Device Catalogue Number: 461008E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 06/01/2020
• Patient Sequence Number: 1
• Patient Age: 16 DA
• Patient Weight: 2