MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 12FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711253

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: there are some cases of enteral probes that are elbowing; some right after the passage, even if via endoscopy, and others after a few hours.

Manufacturer Narrative

A review of the device history record revealed no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no samples provided for evaluation, however a photograph was submitted for evaluation.An elbowing probe can be observed in the photo however, quality specifications and compliance of the product could not be determined from the photo alone; a physical sample is required to perform a thorough inspection of the device.The reported condition could not be confirmed based solely on the photograph.An investigation was conducted with a multifunctional team.The manufacturing process was reviewed.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.There have been no similar cases detected in our manufacturing process for this failure mode.The current process is running according to approved specifications.In addition, qc inspections are performed on the product for material release and production personnel performs a 100% visual inspection during the packaging process in order to detect and discard any product that does not pass due to imperfections.It was concluded that the reported condition could not be confirmed to be generated at the manufacturing facility.The reported condition could not be confirmed to be manufacturing related therefore no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 12FR;43IN W/STYLET
• 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: 10417247
• MDR Text Key: 203317222
• Report Number: 9612030-2020-02573
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2002101564
• Date Manufacturer Received: 08/13/2020
• Patient Sequence Number: 1