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

Model Number	125039
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a communication regarding a bronchoscope getting stuck in broncho-cath tube.It was alleged that the broncho-cath tube malfunctioned and customer had to replace the patient tube.It was reported that they used a non-medtronic bronchoscope.It was indicated that there was no further patient injury.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6942718
• Report Number: 8020889-2017-05157
• Device Sequence Number: 862093
• Product Code: BTS
• UDI-Device Identifier: 30884522008758
• UDI-Public: 30884522008758
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: 03/01/2022
• Device Model Number: 125039
• Device Catalogue Number: 125039
• Device Lot Number: 201703405X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/11/2017
• 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