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 Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

Device 7 of 18.(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 by the product distributor that "the adhesive does not stick properly".Upon clarification it was reported that "the part that sticks to the skin, loosens up and falls off after a few hours".There was no harm reported by end users.No photograph depicting the reported compliant issue submitted by the complainant.

Manufacturer Narrative

Contact office address: (b)(4).As a result of our investigation 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 in capa: 200076307.Adhesion issue ¿ no issues found during manufacturing process of 1772 3m foam used for defective batches.No other complaints reported.Detailed analysis cannot be performed due to fact, that samples were not received.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (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: 9484385
• MDR Text Key: 202999334
• Report Number: 1049092-2019-00254
• 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: distributor,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/12/2023
• Device Model Number: 37449
• Device Lot Number: 18K3017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1