MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number 353/19004

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, preoperatively, the product had a fissure.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: one sample was received that was not in its original packaging with a crack on the body of the filter.The defective sample shows a breakage of the device.This type of defect may be caused by an abnormal mechanical stress on the device during storage or during handling.The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure of the observed condition to the breakage of the device.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DAR
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• MDR Report Key: 7832863
• MDR Text Key: 118874507
• Report Number: 2936999-2018-00553
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• PMA/PMN Number: K941535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 353/19004
• Device Catalogue Number: 353/19004
• Device Lot Number: 17F0452FAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 11/26/2018; 03/04/2019
• Supplement Dates FDA Received: 12/20/2018; 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1