MAUDE Adverse Event Report: COVIDIEN ECON SCT CTH 14FR VAC BR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 1180851147

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the device probe disconnected between the flexible transparent pipe and the rigid green part just before attempting to suck up oral secretions.There was no harm to the patient.

Manufacturer Narrative

Evaluation summary the device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the reported lot number.One (1) opened sample was returned to the manufacturing site.Visual inspection was completed, and the site can confirm the reported issue.A review of the manufacturing line was completed.The root cause is related to the alignment of the tube on the transfer pallet on the moulding machine.A quality alert was generated to make personnel in the manufacturing area aware of the customer complaint.A corrective and preventative action (capa) has been opened to further investigate this issue.The associated data will be fed into the risk management quarterly report and will be used for tracking and trending purposes.

• Brand Name: ECON SCT CTH 14FR VAC BR
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 9681695
• MDR Text Key: 182429258
• Report Number: 9611018-2020-00393
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1180851147
• Device Catalogue Number: 1180851147
• Device Lot Number: 19E152FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2020
• Patient Sequence Number: 1