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

Model Number	5-18537
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: AIRWAY, ESOPHAGEAL (OBTURATOR)
• MDR Report Key: 9310083
• Report Number: 2936999-2019-00934
• Device Sequence Number: 2133273
• Product Code: CAO
• UDI-Device Identifier: 40884521105554
• UDI-Public: 40884521105554
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K875226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2024
• 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
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/28/2020; 03/25/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 02/12/2020; 04/11/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1