MAUDE Adverse Event Report: COVIDIEN CONT. FEEDING SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884741821
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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
The customer reported that the patient used an extension set to feed and the connection where the right angle connects to the line has come away.Leaking occurred as a result.They went on to use another feed set and it happened again.There was no patient injury.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and no abnormal process conditions were present during the manufacturing of the products that could have led to the condition 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.Two samples were received for evaluation in their original packaging.The samples had disassembled adapters.The exact root cause was not determined however a potential root cause is the lack of solvent that is caused by the operator during the assembly process.A re-training was performed with the involved operators.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: CONT. FEEDING SET
• 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: 10091421
• Report Number: 9612030-2020-02474
• Device Sequence Number: 3407046
• Product Code: KNT
• UDI-Device Identifier: 20884521023960
• UDI-Public: 20884521023960
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 8884741821
• Device Catalogue Number: 8884741821
• Device Lot Number: 1912001364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1