MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 20FR X 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	720250
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/10/2020
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 balloon leaked.
Additional Manufacturer Narrative
Please disregard this report number (9612030-2020-02609).Further review of the reported issue determined that this is not a reportable event.The event was originally reported as leaking however further evaluation was completed and determined that this is an internal retention device which is not a reportable malfunction.

• Brand Name: BALLOON SLG 20FR X 2.5CM
• 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: 10528750
• Report Number: 9612030-2020-02609
• Device Sequence Number: 3118472
• Product Code: KNT
• UDI-Device Identifier: 10884521011298
• UDI-Public: 10884521011298
• 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): 10/30/2020

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: 720250
• Device Catalogue Number: 720250
• Device Lot Number: 1924631764
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1