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

Model Number	125035
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	06/27/2017
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
Medtronic received a communication that the blue tube (bronchial) and the transparent tube (tracheal) were found adhered alternatively.Medtronic is following up for additional information.
Additional Manufacturer Narrative
No adverse event has occurred associated to this event; it only product problem.Device analysis: one sample returned for evaluation.Visual examination shows that the tracheal sleeve is contained in the bronchial side of the tubing and the bronchial sleeve is contained in the tracheal side of the tubing.A deviation occurred during the ¿preform and connect¿ operation.A correction and preventive action has been opened to address this issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a communication that the blue tube (bronchial) and the transparent tube (tracheal) were found adhered alternatively.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6734829
• Report Number: 8020889-2017-05081
• Device Sequence Number: 13743474
• Product Code: BTS
• UDI-Device Identifier: 30884522008734
• UDI-Public: 30884522008734
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,user facil
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 11/01/2021
• Device Model Number: 125035
• Device Catalogue Number: 125035
• Device Lot Number: 201611179X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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