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

Model Number	125239
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
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
According to the reporter, a packaging issue occurred, it was stated that a component was incorrect.The customer reported that the tube disconnected and desaturation (spo2=10%) occurred without the possibility to use mechanical ventilation, right lung exclusion, which required urgent return of decubitus dorsal extubation and the new intubation with a conventional tube.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7188024
• Report Number: 8020889-2018-00006
• Device Sequence Number: 11257469
• Product Code: BTS
• UDI-Device Identifier: 10884522008792
• UDI-Public: 10884522008792
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: 125239
• Device Catalogue Number: 125239
• Device Lot Number: 201707052X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR