MAUDE Adverse Event Report: CONVATEC INC SECUREMENTS; ACCESSORIES, CATHETER

Model Number 37449

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 11 of 14.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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 that "the device slowly detach from the skin and a new one needs to be placed." the device was reported in use on the "patient's neck, previously there was always more time adhered (time not informed), now it is necessary to change the device every day, as there is no adherence".It was further reported ¿according to the patient¿s speech, there was no displacement of the patient's gastrostomy tube.No harm reported.No photographs depicting the reported complaint issue was received by the complainant.

Manufacturer Narrative

Correction g1: contact office address: (b)(4).An investigation was performed and retain batches were checked.The results of the investigation showed two main causes were detected: sealing issue: poor seal between flaps and foam due to incorrect sealing settings on the production line which was caused by broken adjustment knob.Corrective actions were defined and implemented.Adhesion issue: no issues found during manufacturing process for defective batches.No other complaints reported.A detailed analysis cannot be performed because no samples were received for inspection.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: (b)(4).Third party manufacturing site: (b)(4).

Event Description

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

• Brand Name: SECUREMENTS
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 9977311
• MDR Text Key: 204627107
• Report Number: 1049092-2020-00121
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2024
• Device Model Number: 37449
• Device Lot Number: 18M3020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1