MAUDE Adverse Event Report: COVIDIEN PVC FEEDING TUBE 5 FR 36; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461008
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional 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. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Per patient one of the tubes was crimped and its restraining or blocking the flow of the fluid.There was no patient harm reported.
Additional Manufacturer Narrative
H6 evaluation codes: component code; type of investigation; investigation findings; investigation conclusion.Investigation summary: a review of the device history record could not be conducted because a lot number was not provided.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.A physical sample was not returned for evaluation however, one picture was provided.After performing a visual inspection of the photo, it appears the tube was trapping in the package seal.Trapping in the seal could cause occlusion or shearing of the tube.The reported issue was confirmed.As part of continuous improvements, a corrective and preventative action has been opened in order to address this type of failure though a more robust investigation.Any actions will be designed to prevent the reoccurrence of the reported condition.

• Brand Name: PVC FEEDING TUBE 5 FR 36
• 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: 11894152
• Report Number: 9612030-2021-02923
• Device Sequence Number: 1388313
• Product Code: KNT
• UDI-Device Identifier: 20884521067360
• UDI-Public: 20884521067360
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 461008
• Device Catalogue Number: 461008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1