MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 24FR X 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 724250

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

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

The customer reported that the product presented leak, where it was observed torn cuff evolving with impossible to use.The customer further stated that balloon exchange was performed with less than 1 month.There was no patient harm reported.

• Brand Name: BALLOON SLG 24FR 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
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10855965
• MDR Text Key: 217359900
• Report Number: 9612030-2020-02695
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521011434
• UDI-Public: 10884521011434
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2020

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
• Device Operator: No Information
• Device Model Number: 724250
• Device Catalogue Number: 724250
• Device Lot Number: 1920433164
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1