MAUDE Adverse Event Report: CONVATEC INC FLEXI-SEAL PROTECT; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	421630
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an intensive care patient exhibited multi-organ failure, and chronic diarrhea, which justified flexi-seal based on nursing benefit.The patient had a flexi-seal protect in place for three weeks."bleeding from the rectum was observed, and a rectoscopy showed circumferential necrosis in the distal rectum.The examination also found that the product was filled with more than 100 ml of water when it should only be filled with less than or equal to 45 ml.The patient was hospitalized for another month and was then discharged.However, the patient was readmitted shortly after with abdominal pain, which is confirmed to be due to obliterating swelling in the distal bowel where the previous injury was noted and is interpreted as a direct effect of this.The patient got operated and got a relieving sigmoid ostomy." per the information provided, the probable cause is "due to a mistake in use where the flushing channel was confused with the cuff, whereby the cuff balloon was enlarged and could cause pressure damage to the intestine.It is quite possible to confuse these as the same syringe can be used with luer coupling.The marking is present but not very clear.".
Additional Manufacturer Narrative
(b)(6).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.

• Brand Name: FLEXI-SEAL PROTECT
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 19339686
• Report Number: 1049092-2024-00063
• Device Sequence Number: 21005977
• Product Code: KNT
• UDI-Device Identifier: 00768455143016
• UDI-Public: 768455143016
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K162906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 421630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male