MAUDE Adverse Event Report: CONVATEC INC FLEXI-SEAL OTHERS; UNKNOWN

Model Number CCC-UNKNOWN FMS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

D1: brand name: flexi-seal.D2a: tubes, gastrointestinal (and accessories).D2b: procode: knt.Affiliation: (b)(6) hospital.Based on the available information, this event is deemed to be a serious injury.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: 1049092, manufacturing site: 8022978.

Event Description

Per the literature review, there was an "observational cohort study between november 2016 and january 2018 of all patients admitted to a single icu.The research protocol was approved as a quality assurance project, with the need for informed consent waived (royal melbourne hospital research ethics committee)." all patients admitted to icu during the 15-month research period were screened daily for the presence of a rectal tube.The decision to insert a rectal tube was made by bedside health care practitioners guided by a local protocol.The protocol included relative contraindications to insertion; for example, local anatomical abnormalities and systemic anticoagulation.All rectal tubes (flexi-seal signal fms; convatec) were inserted by icu nursing staff who had received training in this procedure.Once inserted, ongoing protocol management by the primary nurse aimed to mitigate pressure injury by balloon deflation and volume checks once per shift, and completion twice per day of a checklist designed to confirm that the rectal tube was still clinically warranted and there were no signs of bleeding or excoriation.However, the protocol did not mandate removal for certain post-insertion events, such as commencement of systemic anticoagulation or fall in platelet count.Based on the study, three patients had a major adverse event.In all three cases, patients were noted to have rectal bleeding and progressive anemia, and subsequently found to have rectal mucosal ulceration causing blood loss clinically attributed to the rectal tube.Two patients underwent laparotomy and one patient sigmoidoscopy.These patients received between two and 23 units of packed red blood cells.This emdr is to address patient #1 that had laparotomy.

• Brand Name: FLEXI-SEAL OTHERS
• Type of Device: UNKNOWN
• 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: 16843172
• MDR Text Key: 314268570
• Report Number: 1049092-2023-00057
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CCC-UNKNOWN FMS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1