MAUDE Adverse Event Report: CONVATEC INC FLEXI-SEAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Off-Label Use (1494)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Type  Injury  

Manufacturer Narrative

Brand name: flexi-seal.Common device name: tubes, gastrointestinal (and accessories).Procode: knt.Affiliation: (b)(6).Based on the available information, this event is deemed to be a serious injury.Per the ifu for the flexi-seal product, the syringe is not to be filled over 45ml.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

It was reported the patient experience a "lower gi bleed directly related to the device.There may have been an issue with over-inflation of the balloon.".

• Brand Name: FLEXI-SEAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 16025457
• MDR Text Key: 305978522
• Report Number: 1049092-2022-00551
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female