MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 10FR;43IN W/STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711006E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

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.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 reported the pump set could not be removed from the feeding tube.When the nurse used a hemostat to attempt to remove the pump set, the hub of the feeding tube was ripped out of the y port.There was no harm to the patient.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One decontaminated sample without the original package or lot number was received for evaluation.The reported condition was confirmed.During the investigation with the multidisciplinary team a gemba walk into the manufacturing process was performed.All process and controls were found properly followed including sub-assemblies, and inspections performed to the product.There were no abnormal conditions that could trigger the reported condition.The root cause could not be specifically identified; however, through the analysis of the sample provided for evaluation, and based on the investigations developed on past similar cases, it was concluded that the most likely root cause could be due to the amount of force applied when removing the adapter by the user.No action plan is deemed required since the most probable root cause of the reported condition was identified to be user related.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.

• Brand Name: DOBBHOFF 10FR;43IN W/STYLET EN
• 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: 10815729
• MDR Text Key: 215483600
• Report Number: 9612030-2020-02685
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: 10884521582903
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884711006E
• Device Catalogue Number: 8884711006E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2020
• Patient Sequence Number: 1