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

Model Number	125041
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.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 pilot valve on the endobronchial tube deflated.The customer stated that it was found prior to use, there was no patient involvement with this event.Medtronic has requested additional information regarding the circumstances of the event.
Additional Manufacturer Narrative
The sample was received for analysis and the reported issue was confirmed.A inflation/deflation test was performed and an attempt made to inflate the returned unit.The tracheal cuff inflated but deflated rapidly.Examination of the cuff body confirmed a slit in the cuff body.This type of damage is indicative of coming in contact with a sharp utensil or object.The single wall thickness of the cuff body was measured away from the damaged area and found to be within the blueprint specification.The most probable root cause is the tracheal cuff body came in contact with a sharp utensil or object.Reference instructions for use, sections ¿warnings/precautions¿ where it states ¿various bony anatomical structures (e.G., teeth) within the intubation route or any intubation tools with sharp surfaces present a threat to maintaining cuff integrity.Care must be taken to avoid damaging the thin-walled cuffs during intubation which would create the need to subject the patient to the trauma of extubation and re-intubation.If either cuff is damaged, the tube should not be used.¿ 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report the pilot valve on the endobronchial tube deflated.The customer stated that it was found prior to use, 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: 6506417
• Report Number: 8020889-2017-05012
• Device Sequence Number: 12843
• Product Code: BTS
• UDI-Device Identifier: 30884522008765
• UDI-Public: 30884522008765
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K77L2L9
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: 11/01/2021
• Device Model Number: 125041
• Device Catalogue Number: 125041
• Device Lot Number: 201611509X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1