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

Model Number	125039
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2017
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 the cuff on the endobronchial tube would not deflate.Customer indicated there was no patient involvement with this event.
Additional Manufacturer Narrative
One sample was received for analysis and the reported issue could not be confirmed.A visual inspection was performed in addition to an inflation/deflation test.It was observed all the components were assembled according to manufacturing process and performed within specification.We are unable to determine the cause for this specific event however; the most probable root cause is the end user did not fully depress the white adaptor during the deflation.Manufacturing controls are in place to detect damage and to reduce the potential for occurrence during the manufacturing process.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report the cuff on the endobronchial tube would not deflate.Customer indicated there was no patient involvement with this event.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6598330
• Report Number: 8020889-2017-05044
• Device Sequence Number: 555727
• Product Code: BTS
• UDI-Device Identifier: 30884522008758
• UDI-Public: 30884522008758
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: 05/01/2021
• Device Model Number: 125039
• Device Catalogue Number: 125039
• Device Lot Number: 201605235X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1