MAUDE Adverse Event Report: MALLINCKRODT; AIRWAY, ESOPHAGEAL (OBTURATOR)

Model Number 5-18537

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, prior to use, the device had two small bronchial intubation white sleeves that are leaking and damaged.There was no patient involvement.

Manufacturer Narrative

Evaluation summary: a second sample of device was received for evaluation.The reported event was confirmed.It was observed that the cuff was not properly assembled.An inflation deflation test was performed on both cuffs of the tube and it was observed the white cuff held the air although the latex cuff deflated immediately.A visual inspection was performed on the latex cuff and it was observed the cuff had a tear.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.

Manufacturer Narrative

Additional information: d10, g4, h3, h6 h3 evaluation summary: without the actual complaint sample a full investigation cannot be carried out therefore we are unable to determine the cause for this specific event.Manufacturing controls are in place to detect cuff inflation/deflation defects to reduce the potential for occurrence during the manufacturing process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLINCKRODT
• Type of Device: AIRWAY, ESOPHAGEAL (OBTURATOR)
• MDR Report Key: 9310083
• MDR Text Key: 173751013
• Report Number: 2936999-2019-00934
• Device Sequence Number: 1
• Product Code: CAO
• UDI-Device Identifier: 40884521105554
• UDI-Public: 40884521105554
• Combination Product (y/n): N
• PMA/PMN Number: K875226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5-18537
• Device Catalogue Number: 5-18537
• Device Lot Number: 19E0882JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1