MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 6.5FR X 36; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461438
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 that there was a large hole in the middle of the feeding tube.There was no patient harm.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date added.The device history record (dhr) file was reviewed, and no discrepancy was found according to the failure mode reported.There were no physical samples or pictures submitted with this complaint report.The complaint will be reopened if a sample is received.The reported condition was unable to be confirmed.A walk through of the manufacturing area was performed with the multifunctional team (quality, manufacturing, and engineering).All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections.There were no abnormal conditions found that could trigger the reported condition.No action plan is deemed required at this time.The current process is running according to product specifications, meeting quality acceptance criteria.However, as a precautionary measure, the production personnel were notified about the reported condition for manufacturing awareness.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: POLYUR FEED TUBE 6.5FR X 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: 10945727
• Report Number: 9612030-2020-02703
• Device Sequence Number: 583492
• Product Code: KNT
• UDI-Device Identifier: 10884521067950
• UDI-Public: 10884521067950
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/26/2021

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: 461438
• Device Catalogue Number: 461438
• Device Lot Number: 2021729264
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1