MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 18 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718120
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/20/2019
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 there was an issue with the fitting valve of the accessories and the diet was leaking when undocking.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.The reported condition was confirmed by the sample evaluation.The component nutriport is produced by an external supplier and the assembly process at this plant consists of a pick and place operation.There is no additional inspection on the line that would detect the reported condition before placement into the tray.The root cause confirmation will be provided by the manufacturer (supplier) and will be documented through the supplier corrective action request (scar) notification and response form.A production notification was performed to all personnel to ensure that they are aware of the condition reported by the customer.This site is waiting for the corrective actions implemented by the supplier.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 18 FR X 1.2 CM
• 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: 9764498
• Report Number: 9612030-2020-02421
• Device Sequence Number: 2587879
• Product Code: KNT
• UDI-Device Identifier: 10884521011113
• UDI-Public: 10884521011113
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/30/2020

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: 718120
• Device Catalogue Number: 718120
• Device Lot Number: 1711086964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/30/2020
• Patient Sequence Number: 1