MAUDE Adverse Event Report: CONVATEC INC L3C3950 - FLEXI-SEAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 421630

Device Problem Sharp Edges (4013)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.Mfr site: (b)(4).Initial reporter name and address: (b)(6).Based on the available information, this event is deemed to be a reportable serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported by the user facility that they had a patient who developed a "small injury in the rectum wall and a small necrosis issue".According to the facility "the patient was lying in bed, no mobilisation.They blocked with nacl, not more than 45ml.They paid attention on the red/green indicator during blocking.They had short nails during application." the hospital describes the issue with the device as " the blue marked internal part of the tube was too sharp".

Manufacturer Narrative

(b)(6).Correction (e1): patient country should be germany, not brazil.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site:1049092.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

According the simulation test result, there are no abnormal leakage, breakage and blocking on the retention samples.It shows the balloon/white inflation port can resist the normal usage water pressure and the balloon function is effective.The customer¿s assumption, the blue marked internal part of the tube was too sharp and at the same time the balloon didn´t inflate regularly but only horizontal, have not been found in retention samples.And as the pictures, there are no obviously sharp at the blue marked.All flexi-seal fms had been performed balloon leaking test and appearance full-inspection when the processing process completed.The abnormal product will be detected and will be recorded and stopped export.And there¿s specification for the dimension of blue marked, if the dimension inspection showed abnormal, the product will be recorded and stopped export.3.When the device was inserted into the patient, there may be rectal or anal stenosis and poor rectal tone where the balloon may need larger pressure to fixate the device, this might cause the rectal necrosis due to the balloon pressures.Patients with these phenomenon should not use the device.Since there was no defective products noted the actual operation method and the defective situation might not be known.Therefore, the defective situation is unable to do the further confirmation and analysis.Based on the available information, this event is deemed to be a reportable serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 8022978.

Event Description

To date no additional patient or event details have been received.

• Brand Name: L3C3950 - 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: 12120433
• MDR Text Key: 262483436
• Report Number: 1049092-2021-00076
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K162906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2021

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
• Device Operator: Health Professional
• Device Model Number: 421630
• Device Lot Number: 21FM0503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 12/27/2021
• Supplement Dates FDA Received: 07/07/2021; 12/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1