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: one 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

Pictures were received.The reported event could not be confirmed in those pictures, and without a sample is unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause of the reported condition or implement any corrective action.An inflation test is performed for all combitube products.The operator inspects all products for no leaks and segregates the defective parts.All manufacturing controls were found acceptable and effective to detect the reported event.The severity was assessed as 8 (loss of primary function.) loss of primary function.Device or item inoperable.Replacement or repair is required to obtain desired performance.User or patient very dissatisfied.Major disruption to production line.Likely that 100% of product will be scrapped.Total loss of production or quality data, not recoverable.Information has been added to the database and trends will continue to be monitored.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 9312971
• MDR Text Key: 166320413
• Report Number: 2936999-2019-00935
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 01/28/2020; 03/25/2020
• Supplement Dates FDA Received: 01/29/2020; 04/11/2020
• 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