MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR)

Model Number	125039
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received a report that the endobronchial tube's tracheal cuff didn't inflate completely.This was identified during pre-testing.There was no patient involvement.
Additional Manufacturer Narrative
The reported defect could not be detected on the unit returned for evaluation.One sample was returned for evaluation contained in a sample bag with its original opened unit pack.Visual examination showed that the shape of the tubing has been altered using the stylet wire and the returned unit is contaminated.Further examination showed that the tracheal cuff was stretched over the tracheal cuff notches.The stylet wire was removed from the tubing and 4 mls of air was removed from the tracheal cuff body.The returned unit was inflated.Examination of the tracheal cuff body showed that it was fully inflated.The returned unit was deflated without any issue.The returned unit was inflated and deflated three times and no restrictions were noted.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: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6664019
• Report Number: 8020889-2017-05053
• Device Sequence Number: 57184
• Product Code: BTS
• UDI-Device Identifier: 30884522008758
• UDI-Public: 30884522008758
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: 12/01/2021
• Device Model Number: 125039
• Device Catalogue Number: 125039
• Device Lot Number: 201612430X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1