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

Model Number	8884741821
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
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.
Event or Problem Description
The customer reported that the clipstar fell off two sets.Additional information stated that the issue occurred while disconnecting and that the clipstar came off due to the right angled connection breaking.
Additional Manufacturer Narrative
The model number, catalog number and udi were corrected based on corrected information received on 7-jul-2021.
Additional Manufacturer Narrative
Two decontaminated continuous feeding sets without the original packaging or lot number were received evaluation.The sample was visually checked according to product specifications.The reported condition of a disassembly of the tube to the adapter was confirmed in the 2 samples.The root cause for the disassembly issue may occur if the operator does not ensure that the component is properly assembled.This is the first complaint related to this incident during the last year and there is not a negative trend that indicates a potential issue of the process.Therefore, corrective actions will be limited to manufacturing awareness at this time.A production notification was issued to all personnel to ensure awareness of the condition reported by the customer.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: BOLUS 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: 12131004
• Report Number: 9612030-2021-02972
• Device Sequence Number: 1632033
• Product Code: KNT
• UDI-Device Identifier: 30884521011650
• UDI-Public: 30884521011650
• 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,Followup
• Report Date (Section B): 09/14/2021

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: 8884741821
• Device Catalogue Number: 8884741821
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 06/22/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/07/2021; 09/14/2021
• Patient Sequence Number: 1