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

Model Number 37449

Device Problems Material Separation (1562); Activation, Positioning or Separation Problem (2906); Program or Algorithm Execution Problem (4033); Separation Problem (4043)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

(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 "adhesive tape on the flexi trak did not work as expected"."the tape on the flexi track did not hold the urinary catheter in place, the adhesive came loose from the plate (which located on the leg of the patient)".This issue "led to the urine bag becomes hanging, which gives an increase load on the urine catheter".It was reported by the patient that there was "discomfort", but no other harm reported.There were no photographs depicting the reported complaint issue.

Event Description

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

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).An investigation was performed and retain batches were checked.The results of the investigation showed two main causes were detected: 1) 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.2) 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: 1049092.Third party manufacturing site: 2183581.

• Brand Name: SECUREMENTS
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 9123559
• MDR Text Key: 196259486
• Report Number: 1049092-2019-00231
• 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: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 37449
• Device Lot Number: 19D3004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1