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

Model Number	125032
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided indicates that the sample is expected to be returned for analysis.If the sample is returned, a summary of the analysis will be provided 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 that alleges that air could not be removed from the cuff completely.This was discovered while checking the cuff prior to use on a patient.
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 the shape of the tubing was altered using the stylet wire.The tracheal cuff was stretched over the tracheal cuff notches.Further examination revealed air was contained in the tracheal cuff body and a clear like material flaking from the bronchial cuff body which is not part of our manufacturing process.The stylet wire was placed back into the tubing and the sample deflated without any issue.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 tracheal cuff would not deflate.Customer indicated the issue was found during pre-test, prior to patient use.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6430392
• Report Number: 2936999-2017-05088
• Device Sequence Number: 943153
• 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,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2017

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: 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: 03/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1