MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 3.5 FR X 12; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461355
Medical Device Problem Code	Break (1069)
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 they observed a small pinpoint break beneath the hub of the feeding tube.The tube was removed and replaced with a new feeding tube.This occurred in the nicu of the hospital.There was no patient harm.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No samples were returned for evaluation however, a photo was provided.Based on the digital image it is not possible to confirm the reported condition.The physical sample is required to evaluate the reported condition.If a sample is received at a later date the complaint will be reopened.The root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to manufacturing awareness this time.There is not a negative trend that indicates a potential issue in the process.This incident can be considered an isolated event.The current process is running according to product specifications and meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: POLYUR FEED TUBE 3.5 FR X 12
• 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: 9886084
• Report Number: 9612030-2020-02442
• Device Sequence Number: 14090012
• Product Code: KNT
• UDI-Device Identifier: 10884521067394
• UDI-Public: 10884521067394
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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: 461355
• Device Catalogue Number: 461355
• Device Lot Number: 1911339964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1
• Patient Age: 32 DA