MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461043E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2020
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
Customer reports: the feeding port completely came out and the device the feed spilled out.
Additional Manufacturer Narrative
A device history record (dhr) review was not possible as the reported lot number provided a manufacturing date and expiry date however the serial number is necessary to review a dhr.Regrettably, we were unable to forward the returned sample to the supplier for a more robust investigation due to customs regulations.A product analysis is not able to be performed.A photo was provided however the supplier is unable to determine the root cause based solely on the photograph.All tubes are 100% tested and inspected; tubes could not be packaged if they fail at any stations.From the investigation, no abnormal display was found during the manufacturing process.There are no formal corrective/preventative actions being taken at this time.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10504750
• Report Number: 1282497-2020-09438
• Device Sequence Number: 16939614
• Product Code: KNT
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/28/2020

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: 461043E
• Device Catalogue Number: 461043E
• Device Lot Number: 1243030120
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1