MAUDE Adverse Event Report: COVIDIEN 10FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721055E

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

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 a patient came out of the or with a dobhoff sutured to his left nare.An x-ray was performed to confirm placement and showed the tube needed to be advanced.The tube was advanced by the covering provider and when she attempted to remove the wire, she was unable to do so.The cap that held the wire came off and she attempted to remove the wire with hemostats could not.A new dobhoff was placed without difficulty.The tip of the difficult dobhoff looked slightly different than the one that had the wire that pulled out easily.Just for comparison, the provider tried to pull the wire from another dobhoff fresh from the package and found the wire quite difficult to remove.There was no harm to the patient.

Manufacturer Narrative

One decontaminated sample was received for evaluation.The samples was inspected based per procedure.The reported issue was not confirmed; when the hydromer was activated in the sample, the stylet came out easily.During the investigation, a review through the manufacturing process was conducted.All process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.At this time, no actions are deemed necessary since the reported condition was not confirmed to be manufacturing 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: 10FR X 55 ENTRIFLEX 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: 10774858
• MDR Text Key: 214369975
• Report Number: 9612030-2020-02686
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582989
• UDI-Public: 10884521582989
• 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: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884721055E
• Device Catalogue Number: 8884721055E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Patient Sequence Number: 1