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

Model Number	125032
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
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 regarding an endobronchial tube.The customer reported that while in use on a patient, the physician experienced difficulty inserting and removing the bronchus fiber.Customer indicated there was no patient injury 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 and it was observed that there is evidence of sticky tape on the main stem of the tubing.The returned unit was checked for occlusions using a calibrated rod at the bifurcation junction as per our manufacturing process and found to be within the required specification.The most probable root cause is the end used may have used a suctioning device or scope which was not compatible with our product.Manufacturing controls are in place to detect cuffs with damage and to reduce the potential for occurrence during the manufacturing process.Information has been added to the database and trends will continue to be monitored.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.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6567878
• Report Number: 8020889-2017-05030
• Device Sequence Number: 926624
• Product Code: BTS
• UDI-Device Identifier: 30884522008727
• UDI-Public: 30884522008727
• 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,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2017

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: 08/01/2021
• Device Model Number: 125032
• Device Catalogue Number: 125032
• Device Lot Number: 201608333X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/25/2017
• 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: Other