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

Model Number	8884711006E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem 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.
Additional 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
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10815729
• Report Number: 9612030-2020-02685
• Device Sequence Number: 3501021
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: 10884521582903
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 8884711006E
• Device Catalogue Number: 8884711006E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 02/11/2021
• Patient Sequence Number: 1