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

Model Number 720250

Device Problem Fluid/Blood Leak (1250)

Patient Problem Discomfort (2330)

Event Date 08/10/2020

Event Type  malfunction  

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 Description

Customer reports: the balloon leaked.

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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10528750
• MDR Text Key: 206778513
• Report Number: 9612030-2020-02609
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521011298
• UDI-Public: 10884521011298
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 720250
• Device Catalogue Number: 720250
• Device Lot Number: 1924631764
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2020
• Patient Sequence Number: 1